Cleared Traditional

EVOLUTION ESOPHAGEAL STENT FULLY COVERED, MODELS EVO-FC-18-23-8-E, EVO-FC-18-23-10-E, EVO-FC-18-23-12-E (K093619) - FDA 510(k) Clearance

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

K093619 · Cook Ireland, Ltd. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jun 2010
Decision
206d
Days
Class 2
Risk

K093619 is an FDA 510(k) clearance for the EVOLUTION ESOPHAGEAL STENT FULLY COVERED, MODELS EVO-FC-18-23-8-E, EVO-FC-18-.... Classified as Prosthesis, Esophageal (product code ESW), Class II - Special Controls.

Submitted by Cook Ireland, Ltd. (Limerick, IE). The FDA issued a Cleared decision on June 17, 2010 after a review of 206 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 K093619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2009
Decision Date June 17, 2010
Days to Decision 206 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
76d slower than avg
Panel avg: 130d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ESW Prosthesis, Esophageal
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 - ESW Prosthesis, Esophageal

All 58
Devices cleared under the same product code (ESW) and FDA review panel - the closest regulatory comparables to K093619.
Niti-S Esophageal Stent
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HANAROSTENT Esophagus Upper (CCC)
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Resilience Fully Covered Esophageal Stent System
K251265 · Merit Medical Systems, Inc. · Jul 2025
Ultraflex Esophageal NG Stent System
K233939 · Boston Scientific · Apr 2024
Agile Esophageal Stent System
K233837 · Boston Scientific Corporation · Apr 2024
Esophageal TTS Stent
K240522 · Taewoong Medical · Mar 2024