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FDA 510(k)

Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush

K-Number: K181317 · 2019-02-08

ApplicantWilson-Cook Medical, Inc.
Decision Date2019-02-08
Product CodeFDX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush is a medical device manufactured by Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2019-02-08 under approval number K181317. The device is classified under product code FDX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Wilson-Cook Medical, Inc.. The 510(k) number is K181317.

When was Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush approved by the FDA?

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

What company makes Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush?

Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush is manufactured by Wilson-Cook Medical, Inc..

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.

Related Clinical Trials

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Other Devices by Wilson-Cook Medical, Inc.

K160170Lehman Manometry Catheter K161203Soehendra Stent Retriever K171573Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush K171548Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter K170292Tri-Ex Extraction Balloon With Multiple Sizing K171596ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle

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Related Devices (Code: FDX)

K171573Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushWilson-Cook Medical, Inc. K171607Bronchi and Gastrointestinal Cytology BrushWilson-Cook Medical Inc./Cook Endoscopy K172663Cytology BrushMicro-Tech (Nanjing) 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

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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