Data / Medical devices / South Korea / M.I.Tech Co Ltd
M.I.Tech Co Ltd: FDA-registered device maker in Pyeongtaek Gyeonggi, South Korea, 10 510(k) clearances
M.I.Tech Co Ltd is registered with the FDA (registration 3008146331) in Pyeongtaek Gyeonggi, South Korea. It lists 5 device types. The FDA files 10 510(k) clearances under its listings, the newest dated October 30, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008146331
- Address
- 174, Habuk 2gil, Jinwimyeon, Pyeongtaek Gyeonggi, South Korea, 17706
- Owner or operator
- M.I.Tech Co., Ltd. (10030918)
- Roles
- Manufacturer
- First device listed
- March 29, 2012
- Registered through
- 2026
- Brand names listed
- HANAROSTENT Esophagus Upper (CCC), HANAROSTENT LowAX Colon/Rectum(NNN), HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN), HANAROSTENT LowAx Duodenum/Pylorus(NNN), HANAROSTENT® Benefit Biliary (NNN), HANAROSTENT® Biliary (NNN), HANAROSTENT® Esophageal TTS (CCC) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Prosthesis, Esophageal | ESW | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Tracheal, Expandable | JCT | 2 | Manufacturer | accessdata.fda.gov |
| Stent, Colonic, Metallic, Expandable | MQR | 2 | Manufacturer | accessdata.fda.gov |
| Stent, Metallic, Expandable, Duodenal | MUM | 2 | Manufacturer | accessdata.fda.gov |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 30, 2025 | K253327 | HANAROSTENT Esophagus Upper (CCC) | ESW | Substantially Equivalent | M.I.Tech Co., Ltd. | accessdata.fda.gov |
| November 18, 2021 | K213251 | HANAROSTENT Esophagus Asymmetric (CCC) | ESW | Substantially Equivalent | M.I.Tech Co., Ltd. | accessdata.fda.gov |
| July 23, 2021 | K201160 | HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) | ESW | Substantially Equivalent | M.I.Tech Co., Ltd. | accessdata.fda.gov |
| May 11, 2021 | K202973 | HANAROSTENT Benefit Biliary (NNN) | FGE | Unknown | M.I.Tech Co., Ltd. | accessdata.fda.gov |
| December 31, 2020 | K201342 | HANAROSTENT Trachea/Bronchium (CCC) | JCT | Substantially Equivalent | M.I.Tech Co., Ltd. | accessdata.fda.gov |
| May 20, 2020 | K200860 | HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) | ESW | Substantially Equivalent | M.I.Tech Co., Ltd. | accessdata.fda.gov |
| March 7, 2019 | K190141 | HANAROSTENT LowAx Colon/Rectum (NNN) | MQR | Substantially Equivalent | M.I.Tech Co., Ltd. | accessdata.fda.gov |
| February 11, 2019 | K183396 | HANAROSTENT FASTTM Biliary (NNN) | FGE | Unknown | M.I.Tech Co., Ltd. | accessdata.fda.gov |
| January 10, 2019 | K183616 | HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) | MQR | Substantially Equivalent | M.I.Tech Co., Ltd. | accessdata.fda.gov |
| December 30, 2011 | K111149 | HANAROSTENT BILIARY (NNN) | FGE | Unknown | M.I.Tech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Stent, Colonic, Metallic, Expandable
- All makers of Stent, Metallic, Expandable, Duodenal
- All makers of Prosthesis, Tracheal, Expandable
- All makers of Stents, Drains And Dilators For The Biliary Ducts
- All makers of Prosthesis, Esophageal
Updated October 30, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.