HANAROSTENT Esophagus Asymmetric (CCC)— 510(k) K213251

Substantially Equivalent

M.I.Tech Co., Ltd.

FDA 510(k) clearance K213251 for HANAROSTENT Esophagus Asymmetric (CCC), Substantially Equivalent on 2021-11-18. Applicant: M.I.Tech Co., Ltd..

Clearance details

Applicant: M.I.Tech Co., Ltd.
Product code: Code ESW
Advisory panel: General, Plastic Surgery
Date received: 2021-09-30
Decision date: 2021-11-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Pyeongtaek-Si, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code ESW

product code ESW

Death: 11
Injury: 353
Malfunction: 442
Total: 806

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.