Cleared Traditional

K121430 - EVOLUTION BILIARY STENT SYSTEM

K121430 is the FDA 510(k) clearance for EVOLUTION BILIARY STENT SYSTEM by Cook Ireland, Ltd.. It is a Class 2 Gastroenterology & Urology device (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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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

Submission Details

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
Regulatory Context
Review time vs. panel average
161d slower than avg
Panel avg: 130d · This submission: 291d
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 301
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K121430.
ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET
K131201 · Cook, Inc. · Oct 2013
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
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
CRE DITATATION BALLON
K112994 · Boston Scientific Corporation · Feb 2012