Cleared Special

K040129 - TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING

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

K040129 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K040129

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
94d faster than avg
Panel avg: 131d · This submission: 37d
Pathway characteristics
Modification to existing cleared device.

GCA Device Classification - Class 2, Special Controls

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 25
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
TAUT BALLOON CATHETER, MODEL 50640
K011018 · Taut, Inc. · Jun 2001
ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR
K980917 · Fortune Medical Instrument Corp. · May 1998
WILSON-COOK TRIPLE LUMEN BALLOON STONE EXTRACTOR
K953951 · Wilson-Cook Medical, Inc. · Sep 1995
K040129 · TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING
Download PDF FDA Summary Wilson-Cook Medical, …