Cleared Traditional

K171607 - Bronchi and Gastrointestinal Cytology Brush

K171607 is an FDA 510(k) clearance for Bronchi and Gastrointestinal Cytology Brush, manufactured by Wilson-Cook Medical Inc./Cook Endoscopy. The device is a Class 2 Gastroenterology & Urology device with product code FDX cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K171607 · Wilson-Cook Medical Inc./Cook Endoscopy · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
60d
Days
Class 2
Risk

K171607 is an FDA 510(k) clearance for the Bronchi and Gastrointestinal Cytology Brush. Classified as Endoscopic Cytology Brush (product code FDX), Class II - Special Controls.

Submitted by Wilson-Cook Medical Inc./Cook Endoscopy (Winston-Salem, US). The FDA issued a Cleared decision on July 31, 2017 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Wilson-Cook Medical Inc./Cook Endoscopy devices

FDA 510(k) Submission Details - K171607

510(k) Number K171607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2017
Decision Date July 31, 2017
Days to Decision 60 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 130d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FDX Device Classification - Class 2, Special Controls

Product Code FDX Endoscopic Cytology Brush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Collect Cells For Cytological Evaluation.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FDX Endoscopic Cytology Brush

All 26
Devices cleared under the same product code (FDX) and FDA review panel - the closest regulatory comparables to K171607.
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
K181317 · Wilson-Cook Medical, Inc. · Feb 2019
Cytology Brush
K172663 · Micro-Tech (Nanjing) Co., Ltd. · Mar 2018
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
K171573 · Wilson-Cook Medical, Inc. · Dec 2017
Infinity ERCP Sampling Device
K151889 · United States Endoscopy Group, Inc. · Jul 2015
US ENDOSCOPY CYTOLOGY BRUSH
K103437 · United States Endoscopy Group, Inc. · Dec 2010
COOK IRELAND ECHOBRUSH
K052279 · Cook Ireland, Ltd. · Oct 2005