Cleared Traditional

K053454 - RX HERCULINK ELITE BILIARY STENT SYSTEM

K053454 is an FDA 510(k) clearance for RX HERCULINK ELITE 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 87-day FDA review.

K053454 · Guidant Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
87d
Days
Class 2
Risk

K053454 is an FDA 510(k) clearance for the RX HERCULINK ELITE BILIARY STENT SYSTEM. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Guidant Corporation (Santa Clara, US). The FDA issued a Cleared decision on March 6, 2006 after a review of 87 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 Guidant Corporation devices

FDA 510(k) Submission Details - K053454

510(k) Number K053454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received December 09, 2005
Decision Date March 06, 2006
Days to Decision 87 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
43d faster than avg
Panel avg: 130d · This submission: 87d
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 K053454.
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
LIFESTENT FLEXSTART BILIARY STENT SYSTEM
K053404 · Edwards Lifesciences, LLC · Dec 2005
COOK FORMULA 418 BILIARY STENT SYSTEM
K052539 · Cook, Inc. · Dec 2005
BARD CONFORMEXX BILIARY STENT WITH THE PERFORMAXX GRIP
K052114 · Bard Peripheral Vascular, Inc. · Aug 2005