Introducer Needle
OEM, Custom & Manufacturing
CNCPioneer is a certified introducer needle manufacturer supplying spinal, coaxial, guidewire, vascular, epidural, and interventional radiology introducer needles to medical device OEMs and introducer needle brands worldwide — with competitive introducer needle price, full regulatory documentation, and 24-hour DFM & quote turnaround.
What Is an
Introducer Needle?
An introducer needle is a hollow-bore medical needle used to establish initial percutaneous access to a target anatomical space, vessel, or tissue plane — through which a guidewire, catheter, cannula, or secondary needle is subsequently advanced. The introducer needle serves as the first step in a sequential access procedure: the needle creates the initial tissue pathway, and the therapeutic or diagnostic device follows through or alongside it.
Introducer needles are fundamental to minimally invasive medicine. Without reliable introducer needle access, procedures including central venous catheterization, spinal anesthesia, epidural analgesia, lumbar puncture, interventional radiology catheter placement, and endoscopic intervention would require open surgical approaches with significantly greater patient risk and recovery burden. CNCPioneer manufactures the complete range of introducer needle types for medical device OEM, custom, and wholesale programs.
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Complete introducer needle range Spinal, coaxial, guidewire, vascular, epidural, lumbar puncture, central line, anesthesia, and interventional radiology introducer needle types — all gauges and lengths.
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OEM, custom & wholesale programs Private label introducer needle OEM programs, custom design development, and high-volume introducer needle wholesale supply — from 50-piece prototypes to 500,000+ annual volumes.
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Competitive introducer needle price 40–60% lower than equivalent Western suppliers — China manufacturing economics without compromise on regulatory documentation or product specification.
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Full regulatory documentation Material certifications, dimensional inspection records, functional test records, EO sterilization validation, and Certificate of Conformance — formatted for 510(k), ISO 13485, and EU MDR submissions.
Introducer Needle Sizes
& Gauge Specifications
CNCPioneer manufactures introducer needles across the complete clinical gauge range. Introducer needle sizes are selected based on the inner needle or guidewire diameter that must pass through the introducer lumen and the tissue characteristics of the access pathway.
Introducer Needle 18G
OD 1.27mm · ID 0.84mm. The most widely used gauge for standard spinal anesthesia and central venous access. Compatible with 0.035" guidewires and 25G–27G pencil-point spinal needles.
Introducer Needle 19G
OD 1.07mm · ID 0.69mm. Pencil-point spinal introducer and combined spinal-epidural (CSE) anesthesia systems — stable tissue support for pencil-point spinal needles while minimizing patient discomfort.
Introducer Needle 20G
OD 0.90mm · ID 0.58mm. Fine-gauge introducer preferred for pediatric and ambulatory anesthesia. Compatible with 25G–27G pencil-point spinal needles. Does not accommodate standard 0.035" guidewires.
Introducer Needle 21G
OD 0.82mm · ID 0.51mm. Fine-gauge spinal introducer for diagnostic lumbar puncture and ambulatory spinal anesthesia where minimum tissue disruption and patient comfort are primary design requirements.
Introducer Needle 22G
OD 0.71mm · ID 0.41mm. Miniature coaxial biopsy systems, fine-gauge diagnostic access, and pediatric lumbar puncture — minimum tissue trauma with precise inner lumen dimensions for fine-needle passage.
Custom Gauge Configurations
Non-standard gauge combinations, custom inner-to-outer diameter ratios for proprietary coaxial biopsy systems, and specialty introducer needle configurations from 16G through 25G — available through our introducer needle custom program.
Types of Introducer Needles
We Manufacture
CNCPioneer's introducer needle factory manufactures the complete range of introducer needle types across all clinical specialties and gauge sizes — from the standard spinal introducer needle to specialty interventional radiology and coaxial biopsy configurations.
Spinal Introducer Needle
The most widely used introducer needle type globally — a short (~40mm), large-gauge (18G or 19G) needle that creates the tissue pathway and directional guide for the fine-gauge spinal needle, preventing skin-plug formation and deflection through tough fascial layers.
Pencil Point Spinal Needle with Introducer
The current clinical standard for spinal anesthesia — a matched pencil-point spinal needle and introducer set. Associated with significantly lower rates of post-dural puncture headache (PDPH). Whitacre and Sprotte designs supported.
Coaxial Introducer Needle
A larger-gauge outer needle through which a finer inner needle or catheter is advanced to the target tissue. The standard approach in CT-guided and ultrasound-guided biopsy — enabling multiple sampling passes through a single skin entry point.
Guidewire Introducer Needle
Designed for Seldinger technique vascular and non-vascular access — thin-wall construction maximizes inner lumen diameter for guidewire passage, with a short bevel tip optimized for vessel wall puncture rather than tissue dissection.
Central Line Introducer Needle
The access component of central venous catheter (CVC) insertion kits — reliable vessel puncture with blood flashback confirmation, smooth inner wall for atraumatic guidewire passage, and hub geometry compatible with CVC kit components.
Vascular, Epidural & IR Introducer Needles
Vascular introducer needles with echogenic tip treatment for ultrasound-guided access; anesthesia introducer needles for epidural and CSE techniques; and interventional radiology introducer needles across a wide range of lengths and gauges for image-guided procedures.
Introducer Needle Uses & Clinical Applications
Introducer needle use spans virtually every interventional medical specialty. CNCPioneer supplies OEM introducer needle products to device companies and brands competing across all segments of the global introducer needle market.
Anesthesia & Spinal Access
Spinal introducer needles and pencil point spinal needle with introducer sets for subarachnoid block in surgical anesthesia and obstetric pain management — the largest volume segment of the global introducer needle market.
Interventional Radiology
Interventional radiology introducer needle systems for the full range of image-guided procedures — TIPS, biliary drainage, nephrostomy, abscess drainage, and tumor ablation — in a wide range of lengths and gauges.
Vascular Access & Cardiology
Guidewire introducer needles and central line introducer needles for central venous catheterization using the Seldinger technique — internal jugular, subclavian, and femoral vein catheterization access kits.
Oncology & Biopsy Systems
Coaxial introducer needle systems for CT-guided and ultrasound-guided biopsy procedures — enabling multiple fine-needle aspiration or core biopsy passes through a single fixed outer introducer pathway to the target lesion.
Regional Anesthesia & Pain Management
Epidural introducer needle and anesthesia introducer needle designs for combined spinal-epidural (CSE) techniques and chronic pain management epidural catheter placement — obstetric, surgical, and pain clinic applications.
Drainage procedures
Introducer needles are used to establish precise and controlled percutaneous access for the placement of drainage catheters in the management of abscesses, pleural effusion, and ascites. Under imaging guidance such as ultrasound or CT.
Introducer Needle Manufacturing
Capabilities at CNCPioneer
As an established introducer needle manufacturer, CNCPioneer's precision machining and medical device component manufacturing capabilities cover every element of introducer needle design and production — from needle tube processing and bevel grinding to hub manufacturing, cleanroom assembly, and EO sterilization coordination.
Needle Tube Processing
Thin-wall stainless steel tubing in gauges 16G through 25G. Precision bevel grinding for short bevel, long bevel, and Lancet tip geometries. Echogenic tip treatment for ultrasound visualization. Electropolishing for smooth inner lumen and biocompatibility.
Hub Manufacturing
Precision injection-molded Luer lock and Luer slip hubs in medical-grade polypropylene and polycarbonate. Transparent hub design for blood flashback visualization. Color-coded hub identification by gauge per ISO 6009. Pull-force tested needle-to-hub attachment.
Assembly & Packaging
Cleanroom assembly of needle tube to hub. Stylet insertion and retention testing for introducer needle sets. EO sterilization coordination with qualified sterilization partners. Individual blister pack and peel-open sterile packaging. Custom OEM labeling and private label packaging.
OEM Program Management
Prototype quantities from 50–500 pieces with full regulatory documentation. Introducer needle wholesale programs from 5,000 pieces per SKU. Dedicated production lines for annual volumes above 500,000 pieces. Long-term blanket order scheduling available.
Quality Verification
100% tip geometry inspection under calibrated optical microscopy. Bevel angle measurement and verification. Inner lumen patency verification. Hub pull-force testing per applicable ISO standards. Particulate cleanliness testing per sterile device requirements.
Regulatory Documentation
Material certifications for needle tube and hub materials · Dimensional inspection records · Functional test records (lumen patency, hub pull-force, stylet retention) · Sterilization validation data · Certificate of Conformance · 510(k), ISO 13485, and EU MDR compatible.
Introducer Needle Components
& Manufacturing Details
CNCPioneer's introducer needle factory provides complete product manufacturing capability — needle tube, hub, assembly, and packaging — with materials and processes governed by ISO 10993 biocompatibility and applicable ISO needle standards.
Medical-Grade SS 304 / 316L
Standard needle tube material · ISO 10993 biocompatible · Gauges 16G–25G · Thin-wall and standard-wall configurations
Electropolished Lumen
Smooth inner wall surface · Atraumatic guidewire passage · Reduced particulate shedding · Biocompatibility enhanced
Echogenic Tip Treatment
Ultrasound visualization enhancement · Vascular and interventional radiology introducer needles · Multiple pattern options
Medical-Grade Polypropylene
Standard hub material · ISO 10993 compliant · Luer lock and Luer slip configurations · Color-coded per ISO 6009
Transparent Polycarbonate
Blood flashback visualization · Vascular introducer needle applications · Clear hub design for vessel puncture confirmation
Cleanroom Assembly
Cleanroom-controlled needle-to-hub assembly · Stylet retention testing · Hub pull-force verified · Lot traceability maintained
Short Bevel
Standard spinal and vascular introducer needle tip · Controlled tissue penetration · Compatible with all spinal needle systems
Long Bevel / Lancet
Guidewire and vascular introducer needle tip · Optimized for vessel wall puncture · Thin-wall construction for maximum ID
Custom Tip Profiles
Proprietary tip geometries for introducer needle custom programs · DFM review for bevel angle optimization · 100% optical inspection
Individual Blister Pack
Standard introducer needle retail and clinical packaging · Sterile barrier maintained · Peel-open single-use design
OEM Private Label
Customer brand identity, catalog numbers, and regulatory labeling · Full OEM packaging customization for introducer needle brands
EO Sterilization
EO sterilization coordination with qualified sterilization partners · Sterilization validation data provided · Lot identification labeling
Quality Assurance for
Introducer Needles
CNCPioneer applies rigorous quality protocols to every introducer needle order — covering incoming material through tip geometry inspection, functional testing, cleanliness verification, and full regulatory-compatible documentation.
Incoming Material Inspection
Medical-grade stainless steel tubing verified for wall thickness, outer diameter, inner diameter, and material grade. Hub polymer verified for medical-grade certification and biocompatibility documentation before production release.
Tip Geometry Inspection
100% optical inspection of bevel geometry, tip sharpness, and absence of burrs or surface defects on needle tips. Bevel angle measurement and verification against drawing specifications for every introducer needle lot.
Dimensional Verification
Gauge outer diameter, inner diameter, and length verified by calibrated gauging equipment. Hub dimensions verified by CMM. All critical dimensions documented in inspection records supporting device history file requirements.
Functional Testing
Inner lumen patency verification; hub pull-force testing per applicable ISO standards; stylet retention force for introducer needle sets; needle straightness verification — all results documented in functional test records.
Cleanliness Testing
Particulate cleanliness testing per applicable ISO standards for sterile medical device components. Cleanroom assembly protocols maintained throughout needle tube to hub assembly and packaging operations.
Shipping Documentation
Material certifications, dimensional inspection records, functional test records, and Certificate of Conformance packaged with every introducer needle shipment — formatted for 510(k), ISO 13485, and EU MDR compliance.
Quality System for
Introducer Needle OEM Programs
CNCPioneer's quality system documentation is compatible with ISO 13485 medical device supplier audit requirements and FDA 21 CFR Part 820 device history record requirements.
100% Tip Geometry Inspection
Every introducer needle tip inspected under calibrated optical microscopy — bevel angle, tip sharpness, and surface defect verification documented as inspection records for device history file inclusion.
- 100% optical tip inspection
- Bevel angle verification
- Inspection records per lot
Functional Test Records
Lumen patency, hub pull-force, and stylet retention force verified and documented for every introducer needle lot — functional test records formatted for 510(k) design verification and ISO 13485 device history file requirements.
- Lumen patency verification
- Hub pull-force per ISO standards
- Stylet retention testing
Material Certifications
Medical-grade stainless steel tubing and hub polymer certifications confirming biocompatibility data references and material grade compliance — full lot traceability from material receipt to finished introducer needle shipment.
- Needle tube material certifications
- Hub polymer biocompatibility data
- Full lot traceability
Regulatory Documentation Package
Material certifications, dimensional inspection records, functional test records, particulate cleanliness test records, sterilization validation data, and Certificate of Conformance — formatted for 510(k), ISO 13485, and EU MDR technical file requirements.
- Certificate of Conformance (C of C)
- 510(k) / ISO 13485 / EU MDR compatible
- Sterilization validation data
Introducer Needle FAQ
Common questions from medical device OEMs, introducer needle brands, and healthcare distributors about CNCPioneer's introducer needle manufacturing, OEM, custom, and wholesale programs.
An introducer needle is a hollow-bore needle designed specifically to establish a tissue access pathway through which a secondary device — spinal needle, guidewire, catheter, or biopsy needle — is subsequently advanced. Unlike a standard hypodermic needle used for direct drug injection, the introducer needle's primary function is access creation rather than fluid delivery. Introducer needles are typically shorter and stiffer than the needles they introduce, feature hub designs compatible with stylet insertion and removal, and have inner lumen dimensions precisely matched to the outer diameter of the device that passes through them.
The introducer needle 18G has an outer diameter of 1.27mm and inner diameter of approximately 0.84mm, making it compatible with standard 0.035" guidewires and 25G–27G spinal needles — the most widely used gauge for standard spinal anesthesia and central venous access applications. The introducer needle 20G has a smaller outer diameter of 0.90mm and inner diameter of approximately 0.58mm, used where a finer introducer is preferred for patient comfort, particularly in pediatric and ambulatory anesthesia settings. The 20G introducer needle is compatible with 25G–27G pencil-point spinal needles but does not accommodate standard 0.035" guidewires.
The spinal introducer needle is a short, large-gauge access needle that penetrates skin and subcutaneous tissue to create a stable tissue pathway for the finer diagnostic or anesthetic spinal needle that follows. The spinal needle itself — which may be a pencil-point Whitacre, Sprotte, or cutting-bevel Quincke design — is advanced through the tissue tract created by the spinal introducer needle to reach the subarachnoid space. The spinal introducer needle prevents skin-plug formation on the spinal needle tip and provides directional guidance through tough fascial layers. The two needles work as a system — the spinal introducer needle market is therefore closely linked to the market for fine-gauge pencil-point spinal needles.
Yes. CNCPioneer's introducer needle custom program covers proprietary introducer needle designs including non-standard gauge combinations, custom tip geometries, proprietary hub designs, coaxial introducer needle inner-to-outer diameter ratios for biopsy systems, and specialty introducer needle configurations for novel interventional procedures. Our DFM review process covers needle tube selection, bevel geometry optimization, hub attachment method, and packaging configuration. Full regulatory documentation for 510(k) and CE marking submissions is provided as part of the OEM program.
CNCPioneer accepts prototype and design verification quantities of 50–500 pieces for new introducer needle OEM programs. For introducer needle wholesale supply programs, minimum order quantities start at 5,000 pieces per SKU. High-volume introducer needle wholesale programs with annual volumes above 500,000 pieces are supported with dedicated production lines, blanket order scheduling, and competitive introducer needle cost structures.
CNCPioneer's introducer needle price is typically 40–60% lower than equivalent products from Western introducer needle suppliers at comparable specification and documentation levels. The introducer needle cost advantage reflects China manufacturing economics rather than specification or quality compromise — our introducer needle products are manufactured to the same dimensional specifications, biocompatible material standards, and regulatory documentation requirements as products from established market suppliers. Detailed OEM quotations are available within 24 hours for specific gauge, length, tip geometry, and packaging configurations.
CNCPioneer provides material certifications for needle tube and hub materials confirming medical-grade compliance and biocompatibility data references; dimensional inspection records for tip geometry, gauge, length, and hub dimensions; functional test records for lumen patency, hub pull-force, and stylet retention; particulate cleanliness test records; sterilization validation data from our EO sterilization partners; and Certificate of Conformance. Documentation is formatted to support 510(k) design verification, ISO 13485 device history record, and EU MDR technical file requirements.
CNCPioneer manufactures introducer needles for spinal anesthesia, epidural access, lumbar puncture, central venous catheterization (Seldinger technique), interventional radiology image-guided procedures, coaxial biopsy systems, vascular access, and combined spinal-epidural (CSE) anesthesia. All primary clinical applications for introducer needle use are covered by our OEM manufacturing range, including spinal introducer needles, coaxial introducer needles, guidewire introducer needles, central line introducer needles, and interventional radiology introducer needles.
Get an Introducer Needle Price Quote
Submit your introducer needle specifications and receive a free DFM review and competitive introducer needle price quotation within 24 hours. CNCPioneer's medical device engineering team will review your introducer needle design for manufacturability, confirm material and regulatory compliance, and provide a complete OEM program quotation including prototype, qualification, and volume production pricing.