M.I.Tech Co., Ltd.
M.I.Tech Co., Ltd. appears in FDA public data with 0 recalls, 14 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on October 30, 2025.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 14
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K253327 | HANAROSTENT Esophagus Upper (CCC) | October 30, 2025 |
| K213251 | HANAROSTENT Esophagus Asymmetric (CCC) | November 18, 2021 |
| K201160 | HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) | July 23, 2021 |
| K202973 | HANAROSTENT Benefit Biliary (NNN) | May 11, 2021 |
| K201342 | HANAROSTENT Trachea/Bronchium (CCC) | December 31, 2020 |
| K200860 | HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) | May 20, 2020 |
| K190141 | HANAROSTENT LowAx Colon/Rectum (NNN) | March 7, 2019 |
| K183396 | HANAROSTENT FASTTM Biliary (NNN) | February 11, 2019 |
| K183616 | HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) | January 10, 2019 |
| K180180 | HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) | November 2, 2018 |
| K160893 | HANAROCare ReJu | July 27, 2016 |
| K111149 | HANAROSTENT BILIARY (NNN) | December 30, 2011 |
| K093537 | HANAROSTENT ESOPHAGUS (CCC) | June 4, 2010 |
| K072094 | CHOOSTENT | September 25, 2008 |