HANAROSTENT ESOPHAGUS (CCC)— 510(k) K093537

Substantially Equivalent

M.I.Tech Co., Ltd.

FDA 510(k) clearance K093537 for HANAROSTENT ESOPHAGUS (CCC), Substantially Equivalent on 2010-06-04. 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: 2009-11-16
Decision date: 2010-06-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Buena Park, CA, US

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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.