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Wilson-Cook Bronchoscope Biopsy Forceps

FDA 510(k)

Class II (US FDA 510(k))

510(k) K901348

by Wilson-Cook Medical, Inc.

Identifiers

510(k) Number
K901348 FDA 510(k)
FDA Product Code
EGQ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.4465 FDA 510(k)
Regulation Number
872.4465 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Wilson-Cook Bronchoscope Biopsy Forceps is a bronchoscopy accessory designed to obtain tissue samples from the bronchi and lungs during bronchoscopic procedures. It functions as a forceps instrument that can be introduced through the bronchoscope channel to grasp and retrieve biopsy specimens for pathological analysis.

The device is cleared under FDA 510(k) as a Class II instrument (product code EGQ) and is supplied as a single‑use, disposable accessory. It is intended for use in clinical settings where bronchoscopy is performed, stored in its original packaging until use, and conforms to the regulatory specifications listed in the submission (K901348).

Frequently asked questions

What is the intended clinical use of the Wilson-Cook Bronchoscope Biopsy Forceps?

The forceps are designed as a bronchoscopy accessory to obtain tissue samples from the bronchi and lungs during bronchoscopic procedures, allowing clinicians to grasp and retrieve biopsy specimens for pathological analysis. This use is derived directly from the device description, which specifies its role in bronchoscopy.

Is the Wilson-Cook Bronchoscope Biopsy Forceps a single‑use or reusable device?

The device is supplied as a single‑use, disposable accessory, meaning it is intended to be used once and then discarded. This is explicitly stated in the description, which notes that it is provided in its original packaging for one-time clinical use.

How is the forceps supplied and stored before use?

The forceps are packaged in their original sterile packaging and should be stored until the point of use. The description indicates that it is stored in its original packaging, implying that it remains sterile and ready for immediate use when opened in a clinical setting.

What regulatory pathway was used for the clearance of this device?

The Wilson-Cook Bronchoscope Biopsy Forceps was cleared under the FDA 510(k) pathway as a Class II instrument, with a traditional clearance type and a decision description of "Substantially Equivalent." This information is taken from the regulatory details provided, including the K-number K901348 and clearance type.

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: Captura® Disposable Bronchoscope Biopsy Forceps - Cook Medical, Captura Pro™ Biopsy Forceps - Cook Medical, Captura Disposable Bronchoscope Biopsy Forceps, Captura Disposable Bronchoscope Biopsy Forceps, Captura Disposable Bronchoscope Biopsy Forceps

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) K901348 24 fields · synced Oct 6, 2026