FDA 510(k)

Single Use Hemoclip

Número K: K212669 · 2022-05-27

RequerenteZhejiang Chuangxiang Medical Technology Co., Ltd.

Data da decisão2022-05-27

Código do produtoPKL

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Single Use Hemoclip is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Chuangxiang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-05-27 under 510(k) number K212669. The device is classified under product code PKL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Single Use Hemoclip?

Single Use Hemoclip is a medical device that received FDA 510(k) clearance on 2022-05-27. The listed applicant is Zhejiang Chuangxiang Medical Technology Co., Ltd.. The 510(k) number is K212669.

When did Single Use Hemoclip receive FDA 510(k) clearance?

Single Use Hemoclip received FDA 510(k) clearance on 2022-05-27, under 510(k) number K212669.

Who is the listed applicant for Single Use Hemoclip?

The FDA 510(k) record lists Zhejiang Chuangxiang Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single Use Hemoclip?

The FDA product code for Single Use Hemoclip is PKL.

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Fonte oficial

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