Cleared Traditional

K011018 - TAUT BALLOON CATHETER

K011018 is the FDA 510(k) clearance for TAUT BALLOON CATHETER by Taut, Inc.. It is a Class 2 Gastroenterology & Urology device (product code GCA) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K011018 · Taut, Inc. · Gastroenterology & Urology device
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Jun 2001
Decision
79d
Days
Class 2
Risk

K011018 is an FDA 510(k) clearance for the TAUT BALLOON CATHETER, MODEL 50640. 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 Taut, Inc. (Geneva, US). The FDA issued a Cleared decision on June 22, 2001 after a review of 79 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 Taut, Inc. devices

Submission Details

510(k) Number K011018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2001
Decision Date June 22, 2001
Days to Decision 79 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 130d · This submission: 79d
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 20
Devices cleared under the same product code (GCA) and FDA review panel - the closest regulatory comparables to K011018.
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
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