EVOLUTION COLONIC STENT SYSTEM— 510(k) K113510

Substantially Equivalent

Cook Ireland, Ltd.

FDA 510(k) clearance K113510 for EVOLUTION COLONIC STENT SYSTEM, Substantially Equivalent on 2012-05-17. Applicant: Cook Ireland, Ltd..

Clearance details

Applicant: Cook Ireland, Ltd.
Product code: Code MQR
Advisory panel: General, Plastic Surgery
Date received: 2011-11-28
Decision date: 2012-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Limerick, IE

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Adverse events under product code MQR

product code MQR

Death: 11
Injury: 149
Total: 160

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.