Cleared Traditional

K953951 - WILSON-COOK TRIPLE LUMEN BALLOON STONE ...

K953951 is the FDA 510(k) clearance for WILSON-COOK TRIPLE LUMEN BALLOON STONE ... by Wilson-Cook Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code GCA) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K953951 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
28d
Days
Class 2
Risk

K953951 is an FDA 510(k) clearance for the WILSON-COOK TRIPLE LUMEN BALLOON STONE EXTRACTOR. Classified as Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection (product code GCA), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on September 19, 1995 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - 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 Wilson-Cook Medical, Inc. devices

Submission Details

510(k) Number K953951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1995
Decision Date September 19, 1995
Days to Decision 28 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 130d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5010
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 - GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

All 19
Devices cleared under the same product code (GCA) and FDA review panel - the closest regulatory comparables to K953951.
Tri-Ex Extraction Balloon With Multiple Sizing
K170292 · Wilson-Cook Medical, Inc. · Sep 2017
FUSION QUATTRO EXTRACTION BALLOON XL
K063677 · Wilson-Cook Medical, Inc. · Jan 2007
TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING
K040129 · Wilson-Cook Medical, Inc. · Feb 2004
MICROVASIVE EXTRACTOR, RETRIEVAL BALLOON CATHETER
K931619 · Boston Scientific Corp · Aug 1993
BARD STONE REMOVAL BALLOON CATHETER
K920342 · C.R. Bard, Inc. · Aug 1992
URESIL LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
K915343 · Uresil Corp. · Mar 1992