Cleared Traditional

K052279 - COOK IRELAND ECHOBRUSH

K052279 is the FDA 510(k) clearance for COOK IRELAND ECHOBRUSH by Cook Ireland, Ltd.. It is a Class 2 Gastroenterology & Urology device (product code FDX) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K052279 · Cook Ireland, Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
50d
Days
Class 2
Risk

K052279 is an FDA 510(k) clearance for the COOK IRELAND ECHOBRUSH. Classified as Endoscopic Cytology Brush (product code FDX), Class II - Special Controls.

Submitted by Cook Ireland, Ltd. (Limerick, IE). The FDA issued a Cleared decision on October 11, 2005 after a review of 50 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 Cook Ireland, Ltd. devices

Submission Details

510(k) Number K052279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2005
Decision Date October 11, 2005
Days to Decision 50 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 130d · This submission: 50d
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 25
Devices cleared under the same product code (FDX) and FDA review panel - the closest regulatory comparables to K052279.
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
K171573 · Wilson-Cook Medical, Inc. · Dec 2017
Infinity ERCP Sampling Device
K151889 · United States Endoscopy Group, Inc. · Jul 2015
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
CELL RECOVERY SYSTEM
K965037 · Medical Device Technologies, Inc. · Jan 1997
CELL RECOVERY SYSTEM
K960004 · Medical Device Technologies, Inc. · Mar 1996