Cleared Traditional

K121430 - EVOLUTION BILIARY STENT SYSTEM

K121430 is an FDA 510(k) clearance for EVOLUTION BILIARY STENT SYSTEM, manufactured by Cook Ireland, Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 291-day FDA review.

K121430 · Cook Ireland, Ltd. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Mar 2013
Decision
291d
Days
Class 2
Risk

K121430 is an FDA 510(k) clearance for the EVOLUTION BILIARY STENT SYSTEM. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Cook Ireland, Ltd. (Limerick, IE). The FDA issued a Cleared decision on March 1, 2013 after a review of 291 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 Cook Ireland, Ltd. devices

FDA 510(k) Submission Details - K121430

510(k) Number K121430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received May 14, 2012
Decision Date March 01, 2013
Days to Decision 291 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
160d slower than avg
Panel avg: 131d · This submission: 291d
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 395
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K121430.
LIFESTENT BILIARY STENT SYSTEM, LIFESTENT XL BILIARY STENT SYSTEM
K130792 · C.R. Bard, Inc. · Aug 2013
MAXFORCE BILIARY DILATATION CATHETER AND HURRICANE RX BILIARY CATHETER
K130484 · Boston Scientific Corp · Aug 2013
SUPERA VERITAS
K130591 · Idev Technologies, Inc. · May 2013
SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K122546 · Idev Technologies, Inc. · Dec 2012
WALLFLEXTM BILIARY RX STENT SYSTEM (UNCOVERED, PARTIALLY COVERED, AND FULLY COVERED) WALLFLEXTM BILIARY TRANSHEPATIC STE
K122072 · Boston Scientific Corporation · Sep 2012
SUPERA VERITAS(R) INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K111627 · Idev Technologies, Inc. · Aug 2012