Deflectable Brush Biopsy Set
K-Number: K191485 · 2019-06-26
ApplicantCook Incorporated
Decision Date2019-06-26
Product CodeFDX
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Deflectable Brush Biopsy Set is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2019-06-26 under approval number K191485. 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 Deflectable Brush Biopsy Set?
Deflectable Brush Biopsy Set is a medical device that received FDA 510(k) clearance on 2019-06-26. It is manufactured by Cook Incorporated. The 510(k) number is K191485.
When was Deflectable Brush Biopsy Set approved by the FDA?
Deflectable Brush Biopsy Set received FDA 510(k) clearance on 2019-06-26, under approval number K191485.
What company makes Deflectable Brush Biopsy Set?
Deflectable Brush Biopsy Set is manufactured by Cook Incorporated.
What is the FDA product code for Deflectable Brush Biopsy Set?
The FDA product code for Deflectable Brush Biopsy Set is FDX.
Other Devices by Cook Incorporated
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.
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.