Cleared Special

K063677 - FUSION QUATTRO EXTRACTION BALLOON XL

K063677 is an FDA 510(k) clearance for FUSION QUATTRO EXTRACTION BALLOON XL, 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 25-day FDA review.

K063677 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
25d
Days
Class 2
Risk

K063677 is an FDA 510(k) clearance for the FUSION QUATTRO EXTRACTION BALLOON XL. 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 January 5, 2007 after a review of 25 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

FDA 510(k) Submission Details - K063677

510(k) Number K063677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2006
Decision Date January 05, 2007
Days to Decision 25 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
106d faster than avg
Panel avg: 131d · This submission: 25d
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 22
Devices cleared under the same product code (GCA) and FDA review panel - the closest regulatory comparables to K063677.
Howell D.A.S.H Extraction Balloon with Multiple Sizing
K173659 · Wilson-Cook Medical, Inc. · Jul 2018
Advance Biliary Balloon Catheter
K173414 · Cook Incorporated · Jun 2018
Tri-Ex Extraction Balloon With Multiple Sizing
K170292 · Wilson-Cook Medical, Inc. · Sep 2017
TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING
K040129 · Wilson-Cook Medical, Inc. · Feb 2004
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