K101530

Substantially Equivalent

EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D

Applicant: Cook Ireland, Ltd.
Product code: MUM
Advisory panel: General, Plastic Surgery
Date received: 2010-06-03
Decision date: 2011-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Limerick, IE

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.