Cleared Traditional

EVOLUTION COLONIC STENT SYSTEM (K113510) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K113510 · Cook Ireland, Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
171d
Days
Class 2
Risk

K113510 is an FDA 510(k) clearance for the EVOLUTION COLONIC STENT SYSTEM. Classified as Stent, Colonic, Metallic, Expandable (product code MQR), Class II - Special Controls.

Submitted by Cook Ireland, Ltd. (Limerick, IE). The FDA issued a Cleared decision on May 17, 2012 after a review of 171 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 878.3610 - 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 K113510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2011
Decision Date May 17, 2012
Days to Decision 171 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
41d slower than avg
Panel avg: 130d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQR Stent, Colonic, Metallic, Expandable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3610
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 - MQR Stent, Colonic, Metallic, Expandable

All 15
Devices cleared under the same product code (MQR) and FDA review panel - the closest regulatory comparables to K113510.
WallFlex Colonic Stent System with Anchor Lock Delivery System
K234046 · Boston Scientific Corporation · Mar 2024
WallFlex Colonic Stent System with Anchor Lock Delivery System
K201159 · Boston Scientific Corporation · Aug 2020
WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System
K200257 · Boston Scientific Corporation · Apr 2020
HANAROSTENT LowAx Colon/Rectum (NNN)
K190141 · M.I. Tech Co., Ltd. · Mar 2019
HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)
K183616 · M.I. Tech Co., Ltd. · Jan 2019
HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)
K180180 · M.I. Tech Co., Ltd. · Nov 2018