Cleared Traditional

K902737 - BC BRUSHES

K902737 is an FDA 510(k) clearance for BC BRUSHES, manufactured by Olympus Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FDX cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K902737 · Olympus Corp. · Gastroenterology & Urology device
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Aug 1990
Decision
64d
Days
Class 2
Risk

K902737 is an FDA 510(k) clearance for the BC BRUSHES. Classified as Endoscopic Cytology Brush (product code FDX), Class II - Special Controls.

Submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on August 24, 1990 after a review of 64 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Olympus Corp. devices

FDA 510(k) Submission Details - K902737

510(k) Number K902737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1990
Decision Date August 24, 1990
Days to Decision 64 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
67d faster than avg
Panel avg: 131d · This submission: 64d
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 K902737.
CYTOLOGY BRUSH
K922851 · Annex Medical, Inc. · Aug 1992
CYTOLOGY BRUSH
K913248 · Annex Medical, Inc. · Sep 1991
LAPAROSCOPIC CLEANING BRUSH INSTRUMENT
K911481 · United States Endoscopy Group, Inc. · Apr 1991
GASTROINTESTINAL CYTOLOGY BRUSH
K901435 · Telemed Systems, Inc. · Jul 1990
BRONCHIAL CYTOLOGY BRUSH
K901436 · Telemed Systems, Inc. · Jun 1990
WILSON-COOK CYTOLOGY BRUSHES
K896318 · Wilson-Cook Medical, Inc. · Apr 1990