Cleared Traditional

Bronchi and Gastrointestinal Cytology Brush (K171607) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K171607 · Wilson-Cook Medical Inc./Cook Endoscopy · Gastroenterology & Urology device
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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

Submission Details

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.

Device Classification

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 43
Devices cleared under the same product code (FDX) and FDA review panel - the closest regulatory comparables to K171607.
Single Use Cytology Brush V (BC-V600P-3010)
K250993 · Olympus Medical Systems Corporation · Dec 2025
Single Use Cytology Brush
K220063 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Jul 2022
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes
K192908 · Wilson-Cook Medical, Inc. · Nov 2019
Deflectable Brush Biopsy Set
K191485 · Cook Incorporated · Jun 2019
Brush Biopsy Set
K182231 · Cook Incorporated · May 2019
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
K181317 · Wilson-Cook Medical, Inc. · Feb 2019