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Wilson-Cook Biliary and Gastric Aspiration Needle

FDA 510(k)

Class II (US FDA 510(k))

510(k) K895900

by Wilson-Cook Medical, Inc.

Identifiers

510(k) Number
K895900 FDA 510(k)
FDA Product Code
FCK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1075 FDA 510(k)
Regulation Number
876.1075 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Wilson-Cook Biliary and Gastric Aspiration Needle is a Class II medical device classified under the product code FCK, falling within the categories of instruments for biopsy, suction, and endoscopic procedures. Designed for use in gastroenterology and urology, this device facilitates the aspiration of fluids or debris from the biliary or gastric systems, aiding in diagnostic or therapeutic interventions.

This device is intended for single-use and is supplied sterile. It is intended for use in controlled clinical settings, such as endoscopy suites, and must be handled according to sterile technique. The aspiration needle is regulated under FDA 510(k) clearance (K895900) and adheres to special controls outlined in regulation number 876.1075. No MRI safety information is specified, and sizes or additional technical specifications are not detailed in the provided data.

Frequently asked questions

What is the Wilson-Cook Biliary and Gastric Aspiration Needle used for?

This device is designed for aspirating fluids or debris from the biliary or gastric systems during endoscopic procedures. It aids in both diagnostic evaluations—such as obtaining samples for analysis—and therapeutic interventions, like clearing obstructions or reducing pressure in the biliary tract.

Is the Wilson-Cook Biliary and Gastric Aspiration Needle sterile and single-use?

Yes, the device is supplied sterile and intended for single-use only. This ensures patient safety by preventing cross-contamination and maintains sterility throughout the procedure, which is critical in controlled clinical settings like endoscopy suites.

What regulatory approval does this aspiration needle hold?

The Wilson-Cook Biliary and Gastric Aspiration Needle has received FDA 510(k) clearance under the product code FCK, demonstrating compliance with special controls outlined in regulation number 876.1075. This classification confirms its equivalence to a predicate device and adherence to safety and performance standards.

In which medical specialties is this needle primarily used?

This device is intended for use in gastroenterology and urology. Its design supports procedures where fluid or debris removal from the biliary or gastric systems is necessary, aligning with the clinical needs of these specialties.

How should the Wilson-Cook Biliary and Gastric Aspiration Needle be handled during use?

The needle must be handled using sterile technique throughout the procedure. Since it is single-use and sterile upon packaging, it should remain unopened until immediately before use, and any unused portions should be discarded according to facility protocols for sterile single-use devices.

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: Wilson-cook Biliary and Gastric Aspiration Needle, K895900 - Wilson-cook Biliary and Gastric Aspirat..., Wilson-cook Biliary and Gastric Aspiration Needle, Wilson-Cook Medical Inc./Cook Endoscopy FDA 510(k) Products (2012-2019)

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) K895900 24 fields · synced Oct 6, 2026