FDA 510(k)

Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush

N.º K: K181317 · 2019-02-08

Fecha de decisión2019-02-08

Código de productoFDX

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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)

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 K172663Cytology BrushMicro-Tech (Nanjing) Co., Ltd.

Fuente oficial

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