HANAROSTENT Trachea/Bronchium (CCC)— 510(k) K201342

Substantially Equivalent

M.I.Tech Co., Ltd.

FDA 510(k) clearance K201342 for HANAROSTENT Trachea/Bronchium (CCC), Substantially Equivalent on 2020-12-31. Applicant: M.I.Tech Co., Ltd..

Clearance details

Applicant: M.I.Tech Co., Ltd.
Product code: Code JCT
Advisory panel: General, Plastic Surgery
Date received: 2020-05-20
Decision date: 2020-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pyeongtaek-Si, KR

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Adverse events under product code JCT

product code JCT

Death: 20
Injury: 211
Other: 1
Total: 232

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.