M.I.Tech Co Ltd
Pyeongtaek Gyeonggi, KR
M.I.TECH CO., LTD. appears in FDA device records in Pyeongtaek Gyeonggi, KR. FDA records list 14 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 14 510(k) clearances for M.I.Tech Co Ltd between 2008 and 2025. The busiest year on record is 2019, with 3. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2016 | 1 |
| 2018 | 1 |
| 2019 | 3 |
| 2020 | 2 |
| 2021 | 3 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253327 | HANAROSTENT Esophagus Upper (CCC) | ESW | Substantially Equivalent | |
| K213251 | HANAROSTENT Esophagus Asymmetric (CCC) | ESW | Substantially Equivalent | |
| K201160 | HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) | ESW | Substantially Equivalent | |
| K202973 | HANAROSTENT Benefit Biliary (NNN) | FGE | Unknown | |
| K201342 | HANAROSTENT Trachea/Bronchium (CCC) | JCT | Substantially Equivalent | |
| K200860 | HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) | ESW | Substantially Equivalent | |
| K190141 | HANAROSTENT LowAx Colon/Rectum (NNN) | MQR | Substantially Equivalent | |
| K183396 | HANAROSTENT FASTTM Biliary (NNN) | FGE | Unknown | |
| K183616 | HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) | MQR | Substantially Equivalent | |
| K180180 | HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) | MQR | Substantially Equivalent | |
| K160893 | HANAROCare ReJu | NUH | Substantially Equivalent | |
| K111149 | HANAROSTENT BILIARY (NNN) | FGE | Unknown | |
| K093537 | HANAROSTENT ESOPHAGUS (CCC) | ESW | Substantially Equivalent | |
| K072094 | CHOOSTENT | ESW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3040096051 | 3040096051 | M.I.TECH CO., LTD. | 17-3 Palbok 1-Gil, Jeonju Jeonbuk 54883 KR | 2026 | |
| 3008146331 | 3008146331 | M.I.Tech Co Ltd | 174, Habuk 2gil, Jinwimyeon, Pyeongtaek Gyeonggi 17706 KR | 2026 | |
| 3011458193 | 3011458193 | M.I.Tech Co., Ltd. | 458, Bongeunsa-ro, Gangnam-gu, Seoul 06154 KR | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain