EVOLUTION ESOPHAGEAL STENT SYSTEM— 510(k) K080359

Substantially Equivalent

Cook Ireland, Ltd.

FDA 510(k) clearance K080359 for EVOLUTION ESOPHAGEAL STENT SYSTEM, Substantially Equivalent on 2008-05-09. Applicant: Cook Ireland, Ltd..

Clearance details

Applicant: Cook Ireland, Ltd.
Product code: Code ESW
Advisory panel: General, Plastic Surgery
Date received: 2008-02-11
Decision date: 2008-05-09
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.