Cleared Traditional

K896318 - WILSON-COOK CYTOLOGY BRUSHES

K896318 is an FDA 510(k) clearance for WILSON-COOK CYTOLOGY BRUSHES, manufactured by Wilson-Cook Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FDX cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K896318 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
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Apr 1990
Decision
159d
Days
Class 2
Risk

K896318 is an FDA 510(k) clearance for the WILSON-COOK CYTOLOGY BRUSHES. Classified as Endoscopic Cytology Brush (product code FDX), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on April 9, 1990 after a review of 159 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 Wilson-Cook Medical, Inc. devices

FDA 510(k) Submission Details - K896318

510(k) Number K896318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1989
Decision Date April 09, 1990
Days to Decision 159 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
28d slower than avg
Panel avg: 131d · This submission: 159d
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 36
Devices cleared under the same product code (FDX) and FDA review panel - the closest regulatory comparables to K896318.
BC BRUSHES
K902737 · Olympus Corp. · Aug 1990
GASTROINTESTINAL CYTOLOGY BRUSH
K901435 · Telemed Systems, Inc. · Jul 1990
BRONCHIAL CYTOLOGY BRUSH
K901436 · Telemed Systems, Inc. · Jun 1990
PORGES CYTOLOGY BRUSHES
K896425 · Porges Corp. · Jan 1990
WILTEK CYTOLOGY BRUSH
K894863 · Wiltek Medical, Inc. · Dec 1989
HOBBS MEDICAL MICROBIOLOGY BRUSH
K893729 · Hobbs Medical, Inc. · Aug 1989