Cleared Special

K040129 - TRI-EX EXTRACTION BALLOON WITH MULTIPLE...

K040129 is the FDA 510(k) clearance for TRI-EX EXTRACTION BALLOON WITH MULTIPLE... by Wilson-Cook Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code GCA) cleared through the Special 510(k) pathway after a 37-day FDA review.

K040129 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Feb 2004
Decision
37d
Days
Class 2
Risk

K040129 is an FDA 510(k) clearance for the TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING. 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 February 27, 2004 after a review of 37 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Wilson-Cook Medical, Inc. devices

Submission Details

510(k) Number K040129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2004
Decision Date February 27, 2004
Days to Decision 37 days
Submission Type Special
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
93d faster than avg
Panel avg: 130d · This submission: 37d
Pathway characteristics
Modification to existing cleared device.

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 K040129.
Advance Biliary Balloon Catheter
K173414 · Cook Incorporated · Jun 2018
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
WILSON-COOK TRIPLE LUMEN BALLOON STONE EXTRACTOR
K953951 · Wilson-Cook Medical, Inc. · Sep 1995
MICROVASIVE EXTRACTOR, RETRIEVAL BALLOON CATHETER
K931619 · Boston Scientific Corp · Aug 1993
BARD STONE REMOVAL BALLOON CATHETER
K920342 · C.R. Bard, Inc. · Aug 1992