COOK IRELAND SONNET POLYPECTOMY SNARE— 510(k) K050294

Substantially Equivalent

Cook Ireland, Ltd.

FDA 510(k) clearance K050294 for COOK IRELAND SONNET POLYPECTOMY SNARE, Substantially Equivalent on 2005-03-31. Applicant: Cook Ireland, Ltd..

Clearance details

Applicant: Cook Ireland, Ltd.
Product code: Code FDI
Advisory panel: Gastroenterology, Urology
Date received: 2005-02-07
Decision date: 2005-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Limerick, IE

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Adverse events under product code FDI

product code FDI

Death: 6
Injury: 217
Malfunction: 1,544
Total: 1,767

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.