HANAROSTENT FASTTM Biliary (NNN)— 510(k) K183396

Unknown

M.I.Tech Co., Ltd.

FDA 510(k) clearance K183396 for HANAROSTENT FASTTM Biliary (NNN), Unknown on 2019-02-11. Applicant: M.I.Tech Co., Ltd..

Clearance details

Applicant: M.I.Tech Co., Ltd.
Product code: Code FGE
Advisory panel: Gastroenterology, Urology
Date received: 2018-12-07
Decision date: 2019-02-11
Decision: Unknown
Clearance type: Traditional
Location: Pyeongtaek-Si, KR

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.