Cleared Traditional

K110122 - MUSTANG BALLOON DILATAION CATHETERS

K110122 is an FDA 510(k) clearance for MUSTANG BALLOON DILATAION CATHETERS, manufactured by Boston Scientific. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K110122 · Boston Scientific · Gastroenterology & Urology device
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May 2011
Decision
114d
Days
Class 2
Risk

K110122 is an FDA 510(k) clearance for the MUSTANG BALLOON DILATAION CATHETERS. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Boston Scientific (Maple Grove, US). The FDA issued a Cleared decision on May 12, 2011 after a review of 114 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Boston Scientific devices

FDA 510(k) Submission Details - K110122

510(k) Number K110122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2011
Decision Date May 12, 2011
Days to Decision 114 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
17d faster than avg
Panel avg: 131d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FGE Device Classification - Class 2, Special Controls

Product Code FGE Stents, Drains And Dilators For The Biliary Ducts
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 - FGE Stents, Drains And Dilators For The Biliary Ducts

All 388
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K110122.
CHARGER BALLOON DILATATION CATHETER
K112701 · Boston Scientific · Oct 2011
SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTEMS
K111766 · Idev Technologies, Inc. · Oct 2011
MULTIPURPOSE DRAINAGE CATHETER
K111315 · Navilyst Medical, Inc. · Jun 2011
SINGLE USE BILIARY DRAINAGE STENT V
K103478 · Olympus Medical Systems Corporation · Feb 2011
MULTIPURPOSE DRAINAGE CATHETER
K103353 · Navilyst Medical, Inc. · Jan 2011
EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470
K102082 · Boston Scientific Corp · Aug 2010