Evolution Esophageal Stent System Partially Covered— 510(k) K162717

Substantially Equivalent

Cook Ireland, Ltd.

FDA 510(k) clearance K162717 for Evolution Esophageal Stent System Partially Covered, Substantially Equivalent on 2016-12-21. Applicant: Cook Ireland, Ltd..

Clearance details

Applicant: Cook Ireland, Ltd.
Product code: Code ESW
Advisory panel: General, Plastic Surgery
Date received: 2016-09-29
Decision date: 2016-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Limerick, IE

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Adverse events under product code ESW

product code ESW

Death: 11
Injury: 353
Malfunction: 442
Total: 806

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.