Cleared Traditional

K911481 - LAPAROSCOPIC CLEANING BRUSH INSTRUMENT

K911481 is the FDA 510(k) clearance for LAPAROSCOPIC CLEANING BRUSH INSTRUMENT 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 18-day FDA review.

K911481 · United States Endoscopy Group, Inc. · Gastroenterology & Urology device
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Apr 1991
Decision
18d
Days
Class 2
Risk

K911481 is an FDA 510(k) clearance for the LAPAROSCOPIC CLEANING BRUSH INSTRUMENT. 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 April 22, 1991 after a review of 18 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 United States Endoscopy Group, Inc. devices

Submission Details

510(k) Number K911481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1991
Decision Date April 22, 1991
Days to Decision 18 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
112d faster than avg
Panel avg: 130d · This submission: 18d
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 K911481.
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
CYTOLOGY BRUSH
K924104 · United States Endoscopy Group, Inc. · Nov 1992
BC BRUSHES
K902737 · Olympus Corp. · Aug 1990
WILSON-COOK CYTOLOGY BRUSHES
K896318 · Wilson-Cook Medical, Inc. · Apr 1990
BERGER PROSTATE CULTURE CYTOLOGY BRUSH
K880095 · Van-Tec, Inc. · Mar 1988