FDA 510(k)

Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush

Número K: K181317 · 2019-02-08

Data da decisão2019-02-08

Código do produtoFDX

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2019-02-08 under 510(k) number K181317. 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 Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush?

Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush is a medical device that received FDA 510(k) clearance on 2019-02-08. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K181317.

When did Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush receive FDA 510(k) clearance?

Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush received FDA 510(k) clearance on 2019-02-08, under 510(k) number K181317.

Who is the listed applicant for Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush?

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

What is the FDA product code for Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush?

The FDA product code for Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush is FDX.

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Dispositivos Relacionados (Código: FDX)

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Fonte oficial

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