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FDA 510(k)

Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush

K-Number: K171573 · 2017-12-29

ApplicantWilson-Cook Medical, Inc.
Decision Date2017-12-29
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 2017-12-29 under approval number K171573. 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 2017-12-29. It is manufactured by Wilson-Cook Medical, Inc.. The 510(k) number is K171573.

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 2017-12-29, under approval number K171573.

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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Related Devices (Code: FDX)

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 K181317Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushWilson-Cook Medical, Inc.

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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