Cleared Special

K103437 - US ENDOSCOPY CYTOLOGY BRUSH

K103437 is an FDA 510(k) clearance for US ENDOSCOPY CYTOLOGY BRUSH, manufactured by United States Endoscopy Group, 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.

K103437 · United States Endoscopy Group, Inc. · Gastroenterology & Urology device
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Dec 2010
Decision
30d
Days
Class 2
Risk

K103437 is an FDA 510(k) clearance for the US ENDOSCOPY CYTOLOGY BRUSH. Classified as Endoscopic Cytology Brush (product code FDX), Class II - Special Controls.

Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on December 23, 2010 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.

View all United States Endoscopy Group, Inc. devices

FDA 510(k) Submission Details - K103437

510(k) Number K103437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2010
Decision Date December 23, 2010
Days to Decision 30 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Statement
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 36
Devices cleared under the same product code (FDX) and FDA review panel - the closest regulatory comparables to K103437.
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
K171573 · Wilson-Cook Medical, Inc. · Dec 2017
Bronchi and Gastrointestinal Cytology Brush
K171607 · Wilson-Cook Medical Inc./Cook Endoscopy · Jul 2017
Infinity ERCP Sampling Device
K151889 · United States Endoscopy Group, Inc. · Jul 2015
COOK IRELAND ECHOBRUSH
K052279 · Cook Ireland, Ltd. · Oct 2005
WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH
K040324 · Wilson-Cook Medical, Inc. · May 2004
CELL RECOVERY SYSTEM
K965037 · Medical Device Technologies, Inc. · Jan 1997