Company ยท KR
M.I.Tech Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2025. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 30, 2025 | K253327 | HANAROSTENT Esophagus Upper (CCC) M.I.Tech Co., Ltd., KR | ESW |
| Nov 18, 2021 | K213251 | HANAROSTENT Esophagus Asymmetric (CCC) M.I.Tech Co., Ltd., KR | ESW |
| Jul 23, 2021 | K201160 | HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) M.I.Tech Co., Ltd., KR | ESW |
| May 11, 2021 | K202973 | HANAROSTENT Benefit Biliary (NNN) M.I.Tech Co., Ltd., KR | FGE |
| Dec 31, 2020 | K201342 | HANAROSTENT Trachea/Bronchium (CCC) M.I.Tech Co., Ltd., KR | JCT |
| May 20, 2020 | K200860 | HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) M.I.Tech Co., Ltd., KR | ESW |
| Mar 7, 2019 | K190141 | HANAROSTENT LowAx Colon/Rectum (NNN) M.I.Tech Co., Ltd., KR | MQR |
| Feb 11, 2019 | K183396 | HANAROSTENT FASTTM Biliary (NNN) M.I.Tech Co., Ltd., KR | FGE |
| Jan 10, 2019 | K183616 | HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) M.I.Tech Co., Ltd., KR | MQR |
| Nov 2, 2018 | K180180 | HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) M.I.Tech Co., Ltd., KR | MQR |
| Jul 27, 2016 | K160893 | HANAROCare ReJu M.I.Tech Co., Ltd., KR | NUH |
| Dec 30, 2011 | K111149 | HANAROSTENT BILIARY (NNN) M.I.Tech Co., Ltd. | FGE |
| Jun 4, 2010 | K093537 | HANAROSTENT ESOPHAGUS (CCC) M.I.Tech Co., Ltd. | ESW |
| Sep 25, 2008 | K072094 | CHOOSTENT M.I.Tech Co., Ltd. | ESW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||