RESONANCE METALLIC URETERAL STENT— 510(k) K063742

Substantially Equivalent

Cook Ireland, Ltd.

FDA 510(k) clearance K063742 for RESONANCE METALLIC URETERAL STENT, Substantially Equivalent on 2007-05-08. Applicant: Cook Ireland, Ltd..

Clearance details

Applicant: Cook Ireland, Ltd.
Product code: Code FAD
Advisory panel: Gastroenterology, Urology
Date received: 2006-12-18
Decision date: 2007-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Limerick, IE

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Adverse events under product code FAD

product code FAD

Death: 2
Injury: 858
Malfunction: 2,651
Other: 1
Total: 3,512

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.