K202973

Unknown

HANAROSTENT Benefit Biliary (NNN)

Applicant: M.I.Tech Co., Ltd.
Product code: FGE
Advisory panel: Gastroenterology, Urology
Date received: 2020-09-30
Decision date: 2021-05-11
Decision: Unknown
Clearance type: Traditional
Location: Pyeongtaek-Si, KR

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.