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FDA 510(k)

Disposable Hot Biopsy Forceps

K-Number: K231721 · 2023-12-14

ApplicantBeijing Zksk Technology Co., Ltd.
Decision Date2023-12-14
Product CodeKGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Hot Biopsy Forceps is a medical device manufactured by Beijing Zksk Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-12-14 under approval number K231721. 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 2023-12-14. It is manufactured by Beijing Zksk Technology Co., Ltd.. The 510(k) number is K231721.

When was Disposable Hot Biopsy Forceps approved by the FDA?

Disposable Hot Biopsy Forceps received FDA 510(k) clearance on 2023-12-14, under approval number K231721.

What company makes Disposable Hot Biopsy Forceps?

Disposable Hot Biopsy Forceps is manufactured by Beijing Zksk Technology 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

Other Devices by Beijing Zksk Technology Co., Ltd.

K213217Disposable hemoclip K213222Disposable Polypectomy Snare K213223Multi-Band Ligator K213239Endoscopic Injection Needle K242192Disposable Sphincterotome

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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