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Wilson-Cook Variable Length GI Injection Needle

FDA 510(k)

Class II (US FDA 510(k))

510(k) K941305

by Wilson-Cook Medical, Inc.

Identifiers

510(k) Number
K941305 FDA 510(k)
FDA Product Code
FBK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is an Endoscopic Injection Needle, designed for precise injection into the gastrointestinal mucosa during endoscopic procedures. It features a variable-length mechanism to accommodate different tissue depths and procedural requirements, ensuring controlled fluid or substance delivery during interventions such as submucosal injections or tissue augmentation.

The needle is supplied sterile and intended for single-use only, adhering to standard disposable medical device protocols. It is classified under FDA regulation 876.1500 and holds a FDA 510K clearance (K941305) as substantially equivalent to prior devices. No MRI safety or reusable specifications are noted in the regulatory data.

Manufacturer's product page: AcuJect® Variable Injection Needle

Frequently asked questions

What is the primary use of the Wilson-Cook Variable Length GI Injection Needle during endoscopic procedures?

The Wilson-Cook Variable Length GI Injection Needle is designed for precise injection into the gastrointestinal mucosa during endoscopic procedures. Its variable-length mechanism allows for controlled delivery of fluids or substances at different tissue depths, making it suitable for interventions like submucosal injections or tissue augmentation.

Is this device intended for reuse or is it meant to be used only once?

The device is explicitly intended for single-use only, adhering to standard disposable medical device protocols. This ensures patient safety and sterility, as reuse is not recommended or supported by the manufacturer.

How is the device supplied, and what does this mean for its handling?

The device is supplied sterile, meaning it is pre-sterilized and packaged to maintain its cleanliness until use. This allows clinicians to rely on its readiness for immediate use during procedures without additional sterilization steps, reducing the risk of contamination.

What special considerations should be taken into account when storing this device?

Since the device is sterile and single-use, it should be stored in its original packaging in a clean, dry environment, away from direct sunlight or extreme temperatures. Proper storage ensures the integrity of sterility and functionality until the time of use.

What regulatory pathway was followed for the approval of this device?

The device received FDA clearance through a 510(k) pathway, specifically under the classification of Endoscopic Injection Needle (product code FBK) and regulated under FDA regulation 876.1500. It was determined to be substantially equivalent to prior devices and received clearance on June 2, 1994, with the 510(k) number K941305.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: AcuJect® Variable Injection Needle - Cook Medical, WILSON-COOK VARIABLE LENGTH GI INJECTION NEEDLE (K941305) — FDA 510(k ..., Cook Medical G22525 - NEEDLE, INJECTION, VARIABLE, ACUJECT, VIN-23, EACH, Cook Medical G22525 - NEEDLE, INJECTION, VARIABLE, ACUJECT, VIN-23, EACH

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Wilson-Cook Medical, Inc.

Sources (1)

  • FDA 510(k) K941305 24 fields · synced Oct 6, 2026