M.I.Tech Co., Ltd.
FDA 510(k) & PMA Approved Devices — 11 products
Total Devices11
Categories5
Latest Approval2025-10-30
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K253327 | HANAROSTENT Esophagus Upper (CCC) | ESW | 2025-10-30 | View |
| 510(k) | K213251 | HANAROSTENT Esophagus Asymmetric (CCC) | ESW | 2021-11-18 | View |
| 510(k) | K201160 | HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) | ESW | 2021-07-23 | View |
| 510(k) | K202973 | HANAROSTENT Benefit Biliary (NNN) | FGE | 2021-05-11 | View |
| 510(k) | K201342 | HANAROSTENT Trachea/Bronchium (CCC) | JCT | 2020-12-31 | View |
| 510(k) | K200860 | HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) | ESW | 2020-05-20 | View |
| 510(k) | K190141 | HANAROSTENT LowAx Colon/Rectum (NNN) | MQR | 2019-03-07 | View |
| 510(k) | K183396 | HANAROSTENT FASTTM Biliary (NNN) | FGE | 2019-02-11 | View |
| 510(k) | K183616 | HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) | MQR | 2019-01-10 | View |
| 510(k) | K180180 | HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) | MQR | 2018-11-02 | View |
| 510(k) | K160893 | HANAROCare ReJu | NUH | 2016-07-27 | View |
No matching devices.