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FDA 510(k)

Captura® Disposable Hot Biopsy Forceps

K-Number: K171973 · 2018-03-21

ApplicantWilson-Cook Medical, Inc.
Decision Date2018-03-21
Product CodeKGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Captura® Disposable Hot Biopsy Forceps is a medical device manufactured by Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2018-03-21 under approval number K171973. The device is classified under product code KGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Captura® Disposable Hot Biopsy Forceps?

Captura® Disposable Hot Biopsy Forceps is a medical device that received FDA 510(k) clearance on 2018-03-21. It is manufactured by Wilson-Cook Medical, Inc.. The 510(k) number is K171973.

When was Captura® Disposable Hot Biopsy Forceps approved by the FDA?

Captura® Disposable Hot Biopsy Forceps received FDA 510(k) clearance on 2018-03-21, under approval number K171973.

What company makes Captura® Disposable Hot Biopsy Forceps?

Captura® Disposable Hot Biopsy Forceps is manufactured by Wilson-Cook Medical, Inc..

What is the FDA product code for Captura® Disposable Hot Biopsy Forceps?

The FDA product code for Captura® Disposable Hot Biopsy Forceps is KGE.

Related Clinical Trials

NCT06824402 Cryoprobe Biopsy and Chronic Rejection in Lung Transplant Recipients RECRUITING NCT05751278 Cryoprobe Versus Forceps for Transbronchial Biopsy COMPLETED

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Related Devices (Code: KGE)

K161186Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)Fujifilm Medical Systems U.S.A, Inc. K160625Disposable Hot Biopsy ForcepsMicro-Tech (Nanjing) Co., Ltd. K151474Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)Fujifilm Medical System U.S.A., Inc. K171916Single Use Hot Biopsy Forceps FD-231Olympus Medical Systems Corp. K171096Fujifilm Diathermic Slitter (FlushKnife)Fujifilm Medical Systems U.S.A, Inc. K180018Disposable Hot Biopsy ForcepsMicro-Tech (Nanjing) Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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