FDA 510(k)

Bronchi and Gastrointestinal Cytology Brush

Número K: K171607 · 2017-07-31

RequerenteWilson-Cook Medical Inc./Cook Endoscopy

Data da decisão2017-07-31

Código do produtoFDX

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Bronchi and Gastrointestinal Cytology Brush is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical Inc./Cook Endoscopy. It received FDA 510(k) clearance on 2017-07-31 under 510(k) number K171607. 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 Bronchi and Gastrointestinal Cytology Brush?

Bronchi and Gastrointestinal Cytology Brush is a medical device that received FDA 510(k) clearance on 2017-07-31. The listed applicant is Wilson-Cook Medical Inc./Cook Endoscopy. The 510(k) number is K171607.

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

Bronchi and Gastrointestinal Cytology Brush received FDA 510(k) clearance on 2017-07-31, under 510(k) number K171607.

Who is the listed applicant for Bronchi and Gastrointestinal Cytology Brush?

The FDA 510(k) record lists Wilson-Cook Medical Inc./Cook Endoscopy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bronchi and Gastrointestinal Cytology Brush?

The FDA product code for Bronchi and Gastrointestinal Cytology Brush is FDX.

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Outros registros que listam Wilson-Cook Medical Inc./Cook Endoscopy como candidato(a)

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Dispositivos Relacionados (Código: FDX)

K250993Single Use Cytology Brush V (BC-V600P-3010)Olympus Medical Systems Corporation K220063Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., Ltd.K192908Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushesWilson-Cook Medical, Inc.K191485Deflectable Brush Biopsy SetCook Incorporated K182231Brush Biopsy Set ; Deflectable Brush Biopsy SetCook Incorporated K181317Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushWilson-Cook Medical, Inc.

Fonte oficial

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