FDA 510(k)

Ensure Single-Use Coagulation Forceps

Número K: K202438 · 2021-03-15

RequerenteMicro-Tech (Nanjing) Co., Ltd.

Data da decisão2021-03-15

Código do produtoKGE

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ensure Single-Use Coagulation Forceps is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2021-03-15 under 510(k) number K202438. The device is classified under product code KGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K202438.

When did Ensure Single-Use Coagulation Forceps receive FDA 510(k) clearance?

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

Who is the listed applicant for Ensure Single-Use Coagulation Forceps?

The FDA 510(k) record lists Micro-Tech (Nanjing) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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Dispositivos Relacionados (Código: KGE)

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Fonte oficial

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