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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 the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2018-03-21 under 510(k) 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. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K171973.

When did Captura® Disposable Hot Biopsy Forceps receive FDA 510(k) clearance?

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

Who is the listed applicant for Captura® Disposable Hot Biopsy Forceps?

The FDA 510(k) record lists Wilson-Cook Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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