FDA 510(k)

Single Use Cytology Brush

Número K: K220063 · 2022-07-28

RequerenteZhejiang Chuangxiang Medical Technology Co., Ltd.

Data da decisão2022-07-28

Código do produtoFDX

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Single Use Cytology Brush 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 2022-07-28 under 510(k) number K220063. The device is classified under product code FDX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Single Use Cytology Brush?

Single Use Cytology Brush is a medical device that received FDA 510(k) clearance on 2022-07-28. The listed applicant is Zhejiang Chuangxiang Medical Technology Co., Ltd.. The 510(k) number is K220063.

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

Single Use Cytology Brush received FDA 510(k) clearance on 2022-07-28, under 510(k) number K220063.

Who is the listed applicant for Single Use Cytology Brush?

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 Cytology Brush?

The FDA product code for Single Use Cytology Brush is FDX.

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