FDA 510(k)

Sclerotherapy Needle

Número K: K212668 · 2022-02-23

RequerenteZhejiang Chuangxiang Medical Technology Co., Ltd.

Data da decisão2022-02-23

Código do produtoFBK

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sclerotherapy Needle 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 2022-02-23 under 510(k) number K212668. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sclerotherapy Needle?

Sclerotherapy Needle is a medical device that received FDA 510(k) clearance on 2022-02-23. The listed applicant is Zhejiang Chuangxiang Medical Technology Co., Ltd.. The 510(k) number is K212668.

When did Sclerotherapy Needle receive FDA 510(k) clearance?

Sclerotherapy Needle received FDA 510(k) clearance on 2022-02-23, under 510(k) number K212668.

Who is the listed applicant for Sclerotherapy Needle?

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 Sclerotherapy Needle?

The FDA product code for Sclerotherapy Needle is FBK.

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Fonte oficial

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