Cleared Traditional

K923200 - AMCATH DISPOSABLE CYTOLOGY BRUSH

K923200 is the FDA 510(k) clearance for AMCATH DISPOSABLE CYTOLOGY BRUSH by Intl. Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FDX) cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K923200 · Intl. Medical, Inc. · Gastroenterology & Urology device
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Dec 1992
Decision
160d
Days
Class 2
Risk

K923200 is an FDA 510(k) clearance for the AMCATH DISPOSABLE CYTOLOGY BRUSH. Classified as Endoscopic Cytology Brush (product code FDX), Class II - Special Controls.

Submitted by Intl. Medical, Inc. (Danielson, US). The FDA issued a Cleared decision on December 7, 1992 after a review of 160 days - an extended review cycle.

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 Intl. Medical, Inc. devices

Submission Details

510(k) Number K923200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1992
Decision Date December 07, 1992
Days to Decision 160 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
30d slower than avg
Panel avg: 130d · This submission: 160d
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 18
Devices cleared under the same product code (FDX) and FDA review panel - the closest regulatory comparables to K923200.
US ENDOSCOPY CYTOLOGY BRUSH
K103437 · United States Endoscopy Group, Inc. · Dec 2010
WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH
K040324 · Wilson-Cook Medical, Inc. · May 2004
COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM
K930348 · Boston Scientific Corp · Sep 1993
CYTOLOGY BRUSH
K924104 · United States Endoscopy Group, Inc. · Nov 1992
LAPAROSCOPIC CLEANING BRUSH INSTRUMENT
K911481 · United States Endoscopy Group, Inc. · Apr 1991
BC BRUSHES
K902737 · Olympus Corp. · Aug 1990