Cleared Traditional

K053459 - OMNILINK .035 BILIARY STENT SYSTEM

K053459 is an FDA 510(k) clearance for OMNILINK .035 BILIARY STENT SYSTEM, manufactured by Guidant Corporation. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K053459 · Guidant Corporation · Gastroenterology & Urology device
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Apr 2006
Decision
120d
Days
Class 2
Risk

K053459 is an FDA 510(k) clearance for the OMNILINK .035 BILIARY STENT SYSTEM. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Guidant Corporation (Temecula, US). The FDA issued a Cleared decision on April 12, 2006 after a review of 120 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 Guidant Corporation devices

FDA 510(k) Submission Details - K053459

510(k) Number K053459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received December 13, 2005
Decision Date April 12, 2006
Days to Decision 120 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 130d · This submission: 120d
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 314
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K053459.
MARATHON STENT WITH FUSION TECHNOLOGY
K060624 · Cook Ireland, Ltd. · Aug 2006
LIFESTENT TURBO BILIARY STENT SYSTEM
K061235 · Edwards Lifesciences, LLC · Jun 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
PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM
K060057 · Ev3, Inc. · Mar 2006