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

Name: FDA 510(k) clearance K201342
Creator: U.S. Food and Drug Administration
Published: 2020-12-31

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.. Device class: 2.

Clearance details

Applicant: M.I.Tech Co., Ltd.
Product code: Code JCT
Device class: Class 2
Regulation: 21 CFR 878.3720
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

Download summary PDF View on FDA.gov ↗

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K201160 — HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)2021-07-23
K202973 — HANAROSTENT Benefit Biliary (NNN)2021-05-11
K200860 — HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)2020-05-20

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.