Cleared Traditional

K924104 - CYTOLOGY BRUSH

K924104 is the FDA 510(k) clearance for CYTOLOGY BRUSH by United States Endoscopy Group, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FDX) cleared through the Traditional 510(k) pathway after a 103-day FDA review.

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
Combination Product No
PCCP Authorized No
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 20
Devices cleared under the same product code (FDX) and FDA review panel - the closest regulatory comparables to K924104.
WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH
K040324 · Wilson-Cook Medical, Inc. · May 2004
MEGA-BRUSH, ENDOSCOPIC MASS CYTOLOGY - CELLUAR RETRIEVAL SYSTEM
K944614 · Biosearch Medical Products, Inc. · Apr 1995
COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM
K930348 · Boston Scientific Corp · Sep 1993
LAPAROSCOPIC CLEANING BRUSH INSTRUMENT
K911481 · United States Endoscopy Group, Inc. · Apr 1991
BC BRUSHES
K902737 · Olympus Corp. · Aug 1990
WILSON-COOK CYTOLOGY BRUSHES
K896318 · Wilson-Cook Medical, Inc. · Apr 1990