Zilver 518 Biliary Stent, Zilver 635 Biliary Stent— 510(k) K182980

Unknown

Cook Ireland, Ltd.

FDA 510(k) clearance K182980 for Zilver 518 Biliary Stent, Zilver 635 Biliary Stent, Unknown on 2018-11-16. Applicant: Cook Ireland, Ltd..

Clearance details

Applicant: Cook Ireland, Ltd.
Product code: Code FGE
Advisory panel: Gastroenterology, Urology
Date received: 2018-10-29
Decision date: 2018-11-16
Decision: Unknown
Clearance type: Special
Location: Limerick, IE

Download summary PDF View on FDA.gov ↗

Adverse events under product code FGE

product code FGE

Death: 52
Injury: 2,347
Malfunction: 9,798
Other: 1
Total: 12,198

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.