Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered— 510(k) K163468

Substantially Equivalent

Cook Ireland, Ltd.

FDA 510(k) clearance K163468 for Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered, Substantially Equivalent on 2017-05-04. Applicant: Cook Ireland, Ltd..

Clearance details

Applicant: Cook Ireland, Ltd.
Product code: Code MUM
Advisory panel: General, Plastic Surgery
Date received: 2016-12-12
Decision date: 2017-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Limerick, IE

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Adverse events under product code MUM

product code MUM

Death: 6
Injury: 137
Total: 143

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.