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FDA 510(k)

Disposable Hot Biopsy Forceps

K-Number: K180018 · 2018-07-05

ApplicantMicro-Tech (Nanjing) Co., Ltd.
Decision Date2018-07-05
Product CodeKGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Hot Biopsy Forceps is a medical device manufactured by Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2018-07-05 under approval number K180018. 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 Disposable Hot Biopsy Forceps?

Disposable Hot Biopsy Forceps is a medical device that received FDA 510(k) clearance on 2018-07-05. It is manufactured by Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K180018.

When was Disposable Hot Biopsy Forceps approved by the FDA?

Disposable Hot Biopsy Forceps received FDA 510(k) clearance on 2018-07-05, under approval number K180018.

What company makes Disposable Hot Biopsy Forceps?

Disposable Hot Biopsy Forceps is manufactured by Micro-Tech (Nanjing) Co., Ltd..

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

The FDA product code for 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. K180134Ensizor Monopolar Endoscopic ScissorsSlater Endoscopy, LLC

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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