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FDA 510(k)

Brush Biopsy Set ; Deflectable Brush Biopsy Set

K-Number: K182231 · 2019-05-01

ApplicantCook Incorporated
Decision Date2019-05-01
Product CodeFDX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Brush Biopsy Set ; Deflectable Brush Biopsy Set is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2019-05-01 under approval number K182231. 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 Brush Biopsy Set ; Deflectable Brush Biopsy Set?

Brush Biopsy Set ; Deflectable Brush Biopsy Set is a medical device that received FDA 510(k) clearance on 2019-05-01. It is manufactured by Cook Incorporated. The 510(k) number is K182231.

When was Brush Biopsy Set ; Deflectable Brush Biopsy Set approved by the FDA?

Brush Biopsy Set ; Deflectable Brush Biopsy Set received FDA 510(k) clearance on 2019-05-01, under approval number K182231.

What company makes Brush Biopsy Set ; Deflectable Brush Biopsy Set?

Brush Biopsy Set ; Deflectable Brush Biopsy Set is manufactured by Cook Incorporated.

What is the FDA product code for Brush Biopsy Set ; Deflectable Brush Biopsy Set?

The FDA product code for Brush Biopsy Set ; Deflectable Brush Biopsy Set is FDX.

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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 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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