Cleared Traditional

CYTOLOGY BRUSH (K924104) - FDA 510(k) Clearance

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

K924104 · United States Endoscopy Group, Inc. · Gastroenterology & Urology device
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Nov 1992
Decision
103d
Days
Class 2
Risk

K924104 is an FDA 510(k) clearance for the 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 November 24, 1992 after a review of 103 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all United States Endoscopy Group, Inc. devices

Submission Details

510(k) Number K924104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1992
Decision Date November 24, 1992
Days to Decision 103 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 130d · This submission: 103d
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 K924104.
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