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Howell Biliary Aspiration Needle

FDA 510(k)

Class II (US FDA 510(k))

510(k) K153763

by Wilson-Cook Medical, Inc.

Identifiers

510(k) Number
K153763 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 Howell Biliary Aspiration Needle is a biopsy, suction instrument designed for aspiration procedures within the biliary system. Classified under 21 CFR 876.1075, it is intended for obtaining tissue samples or fluids from bile ducts, aiding in diagnostic evaluations such as cholangiocarcinoma or biliary obstruction assessment. Its design incorporates a needle-based mechanism to safely extract samples while minimizing trauma to surrounding tissues.

This device is supplied as a single-use, sterile instrument and is regulated under FDA 510(k) clearance (K153763) as a Class II medical device. It is intended for use in gastroenterology and urology settings, adhering to product code FCK for biliary-related procedures. Storage requires adherence to manufacturer guidelines to maintain sterility, and its use is governed by 21 CFR Part 820 quality system regulations. No MRI safety labeling is specified.

Frequently asked questions

What is the Howell Biliary Aspiration Needle used for?

The Howell Biliary Aspiration Needle is designed specifically for obtaining tissue samples or fluids from bile ducts during diagnostic procedures. Its primary applications include evaluating conditions such as cholangiocarcinoma (bile duct cancer) or assessing biliary obstructions. The needle’s suction mechanism allows for precise sample extraction while minimizing trauma to surrounding tissues, making it ideal for procedures in the biliary system.

Is the Howell Biliary Aspiration Needle single-use or reusable?

This device is intended for single-use only. It is supplied sterile to ensure patient safety and prevent cross-contamination between procedures. After use, it must be discarded in accordance with medical waste disposal guidelines to maintain sterility and regulatory compliance.

How should the Howell Biliary Aspiration Needle be stored?

Storage must follow the manufacturer’s guidelines to preserve sterility. The device should be kept in its original, unopened packaging until ready for use. Exposure to moisture, extreme temperatures, or contamination can compromise sterility, so it should be stored in a clean, dry environment away from direct sunlight or sources of heat.

In which clinical settings is this needle approved for use?

The Howell Biliary Aspiration Needle is approved for use in gastroenterology and urology settings. Its design aligns with procedures requiring precise biliary sampling, such as endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC). The device’s regulatory classification under 21 CFR 876.1075 reflects its specialized role in biliary diagnostics.

What regulatory pathway does this device follow?

The Howell Biliary Aspiration Needle is classified as a Class II medical device under the FDA’s 510(k) clearance pathway, with the clearance number K153763. This designation means it has been determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and effectiveness standards. The device is also governed by 21 CFR Part 820 quality system regulations.

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: Howell Biliary Aspiration Needle (K153763) — FDA 510 (k) | Innolitics, K153763 FDA 510 (k) - Howell Biliary Aspiration Needle, Howell Biliary Aspiration Needle 510 (k) K153763 - FDA.report, Howell Biliary Aspiration Needle — FDA 510 (k) K153763 | MedTracker, PDF K153763 - Howell Biliary Aspiration Needle

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) K153763 24 fields · synced Oct 1, 2026