Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Bronchi and Gastrointestinal Cytology Brush

K-Number: K171607 · 2017-07-31

ApplicantWilson-Cook Medical Inc./Cook Endoscopy
Decision Date2017-07-31
Product CodeFDX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Bronchi and Gastrointestinal Cytology Brush is a medical device manufactured by Wilson-Cook Medical Inc./Cook Endoscopy. It received FDA 510(k) clearance on 2017-07-31 under approval number K171607. 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 Bronchi and Gastrointestinal Cytology Brush?

Bronchi and Gastrointestinal Cytology Brush is a medical device that received FDA 510(k) clearance on 2017-07-31. It is manufactured by Wilson-Cook Medical Inc./Cook Endoscopy. The 510(k) number is K171607.

When was Bronchi and Gastrointestinal Cytology Brush approved by the FDA?

Bronchi and Gastrointestinal Cytology Brush received FDA 510(k) clearance on 2017-07-31, under approval number K171607.

What company makes Bronchi and Gastrointestinal Cytology Brush?

Bronchi and Gastrointestinal Cytology Brush is manufactured by Wilson-Cook Medical Inc./Cook Endoscopy.

What is the FDA product code for Bronchi and Gastrointestinal Cytology Brush?

The FDA product code for Bronchi and Gastrointestinal Cytology Brush is FDX.

Other Devices by Wilson-Cook Medical Inc./Cook Endoscopy

K171993Zimmon Needle Knife Papillotome K172665Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords K172288Fusion OMNI Sphincterotome K190829Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)

Related Devices (Code: FDX)

K171573Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushWilson-Cook Medical, Inc. 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.

↑