Cleared Traditional

K130792 - LIFESTENT BILIARY STENT SYSTEM

K130792 is the FDA 510(k) clearance for LIFESTENT BILIARY STENT SYSTEM by C.R. Bard, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K130792 · C.R. Bard, Inc. · Gastroenterology & Urology device
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Aug 2013
Decision
161d
Days
Class 2
Risk

K130792 is an FDA 510(k) clearance for the LIFESTENT BILIARY STENT SYSTEM, LIFESTENT XL BILIARY STENT SYSTEM. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on August 30, 2013 after a review of 161 days - an extended review 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: 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K130792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received March 22, 2013
Decision Date August 30, 2013
Days to Decision 161 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
31d slower than avg
Panel avg: 130d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 244
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K130792.
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K133700 · Boston Scientific Corporation · May 2014
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K130981 · Cordis Corp. · Mar 2014
ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET
K131201 · Cook, Inc. · Oct 2013
MAXFORCE BILIARY DILATATION CATHETER AND HURRICANE RX BILIARY CATHETER
K130484 · Boston Scientific Corp · Aug 2013
WALLFLEXTM BILIARY RX STENT SYSTEM (UNCOVERED, PARTIALLY COVERED, AND FULLY COVERED) WALLFLEXTM BILIARY TRANSHEPATIC STE
K122072 · Boston Scientific Corporation · Sep 2012
RESOLVE BILIARY LOCKING DRAINAGE CATHETER
K121832 · Merit Medical Systems, Inc. · Jul 2012