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FDA 510(k)

Ensure Single-Use Coagulation Forceps

K-Number: K202438 · 2021-03-15

ApplicantMicro-Tech (Nanjing) Co., Ltd.
Decision Date2021-03-15
Product CodeKGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Ensure Single-Use Coagulation Forceps is a medical device manufactured by Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2021-03-15 under approval number K202438. 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 Ensure Single-Use Coagulation Forceps?

Ensure Single-Use Coagulation Forceps is a medical device that received FDA 510(k) clearance on 2021-03-15. It is manufactured by Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K202438.

When was Ensure Single-Use Coagulation Forceps approved by the FDA?

Ensure Single-Use Coagulation Forceps received FDA 510(k) clearance on 2021-03-15, under approval number K202438.

What company makes Ensure Single-Use Coagulation Forceps?

Ensure Single-Use Coagulation Forceps is manufactured by Micro-Tech (Nanjing) Co., Ltd..

What is the FDA product code for Ensure Single-Use Coagulation Forceps?

The FDA product code for Ensure Single-Use Coagulation Forceps is KGE.

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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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