FDA 510(k)

Cytology Brush

Número K: K172663 · 2018-03-05

RequerenteMicro-Tech (Nanjing) Co., Ltd.

Data da decisão2018-03-05

Código do produtoFDX

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Cytology Brush 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 2018-03-05 under 510(k) number K172663. 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 Cytology Brush?

Cytology Brush is a medical device that received FDA 510(k) clearance on 2018-03-05. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K172663.

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

Cytology Brush received FDA 510(k) clearance on 2018-03-05, under 510(k) number K172663.

Who is the listed applicant for Cytology Brush?

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 Cytology Brush?

The FDA product code for Cytology Brush is FDX.

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Fonte oficial

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