Cleared Special

US ENDOSCOPY CYTOLOGY BRUSH (K103437) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 130d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 K103437.
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