Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set— 510(k) K180868

Substantially Equivalent

Cook Ireland

FDA 510(k) clearance K180868 for Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set, Substantially Equivalent on 2018-07-06. Applicant: Cook Ireland.

Clearance details

Applicant: Cook Ireland
Product code: Code FGE
Advisory panel: Gastroenterology, Urology
Date received: 2018-04-03
Decision date: 2018-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Limerick, IE

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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.