Cleared Special

K192908 - Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes

K192908 is an FDA 510(k) clearance for Fusion Cytology Brush, manufactured by Wilson-Cook Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FDX cleared through the Special 510(k) pathway after a 30-day FDA review.

K192908 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2019
Decision
30d
Days
Class 2
Risk

K192908 is an FDA 510(k) clearance for the Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes. Classified as Endoscopic Cytology Brush (product code FDX), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on November 14, 2019 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K192908

510(k) Number K192908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2019
Decision Date November 14, 2019
Days to Decision 30 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 131d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 43
Devices cleared under the same product code (FDX) and FDA review panel - the closest regulatory comparables to K192908.
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
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
Cytology Brush
K172663 · Micro-Tech (Nanjing) Co., Ltd. · Mar 2018
K192908 · Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes
Download PDF FDA Summary Wilson-Cook Medical, …