Cleared Special

K061235 - LIFESTENT TURBO BILIARY STENT SYSTEM

K061235 is an FDA 510(k) clearance for LIFESTENT TURBO BILIARY STENT SYSTEM, manufactured by Edwards Lifesciences, LLC. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Special 510(k) pathway after a 33-day FDA review.

K061235 · Edwards Lifesciences, LLC · Gastroenterology & Urology device
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Jun 2006
Decision
33d
Days
Class 2
Risk

K061235 is an FDA 510(k) clearance for the LIFESTENT TURBO BILIARY STENT SYSTEM. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on June 5, 2006 after a review of 33 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 Edwards Lifesciences, LLC devices

FDA 510(k) Submission Details - K061235

510(k) Number K061235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received May 03, 2006
Decision Date June 05, 2006
Days to Decision 33 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
97d faster than avg
Panel avg: 130d · This submission: 33d
Pathway characteristics
Modification to existing cleared device.

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 317
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K061235.
WELLFLEX BILIARY RX STENT SYSTEM
K061231 · Boston Scientific Corp · Sep 2006
PRIMUS GPS BILIARY STENT SYSTEM
K061566 · Ev3, Inc. · Aug 2006
MARATHON STENT WITH FUSION TECHNOLOGY
K060624 · Cook Ireland, Ltd. · Aug 2006
PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX
K060877 · Cordis Corp. · Apr 2006
LIFESTENT FLEXSTAR XL BILIARY STENT SYSTEM
K060487 · Edwards Lifesciences, LLC · Mar 2006
ANGIODYNAMICS TOTAL ABSCESSION BILIARY DRAINAGE CATHETER
K060023 · AngioDynamics, Inc. · Mar 2006