FDA 510(k)

Sclerotherapy Needle

N.º K: K212668 · 2022-02-23

SolicitanteZhejiang Chuangxiang Medical Technology Co., Ltd.

Fecha de decisión2022-02-23

Código de productoFBK

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Fuente oficial

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