Cleared Traditional

K901435 - GASTROINTESTINAL CYTOLOGY BRUSH

K901435 is an FDA 510(k) clearance for GASTROINTESTINAL CYTOLOGY BRUSH, manufactured by Telemed Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FDX cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K901435 · Telemed Systems, Inc. · Gastroenterology & Urology device
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Jul 1990
Decision
112d
Days
Class 2
Risk

K901435 is an FDA 510(k) clearance for the GASTROINTESTINAL CYTOLOGY BRUSH. Classified as Endoscopic Cytology Brush (product code FDX), Class II - Special Controls.

Submitted by Telemed Systems, Inc. (Hudson, US). The FDA issued a Cleared decision on July 16, 1990 after a review of 112 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 Telemed Systems, Inc. devices

FDA 510(k) Submission Details - K901435

510(k) Number K901435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1990
Decision Date July 16, 1990
Days to Decision 112 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 130d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 31
Devices cleared under the same product code (FDX) and FDA review panel - the closest regulatory comparables to K901435.
CYTOLOGY BRUSH
K913248 · Annex Medical, Inc. · Sep 1991
LAPAROSCOPIC CLEANING BRUSH INSTRUMENT
K911481 · United States Endoscopy Group, Inc. · Apr 1991
BC BRUSHES
K902737 · Olympus Corp. · Aug 1990
BRONCHIAL CYTOLOGY BRUSH
K901436 · Telemed Systems, Inc. · Jun 1990
WILSON-COOK CYTOLOGY BRUSHES
K896318 · Wilson-Cook Medical, Inc. · Apr 1990
WILTEK CYTOLOGY BRUSH
K894863 · Wiltek Medical, Inc. · Dec 1989