Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list M.I.Tech with 14 510(k) clearances. The most recent is a 510(k) clearance dated Oct 30, 2025: HANAROSTENT Esophagus Upper (CCC).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 30, 2025 | HANAROSTENT Esophagus Upper (CCC)K253327 · ESW | 510(k) clearances |
| Nov 18, 2021 | HANAROSTENT Esophagus Asymmetric (CCC)K213251 · ESW | 510(k) clearances |
| Jul 23, 2021 | HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)K201160 · ESW | 510(k) clearances |
| May 11, 2021 | HANAROSTENT Benefit Biliary (NNN)K202973 · FGE | 510(k) clearances |
| Dec 31, 2020 | HANAROSTENT Trachea/Bronchium (CCC)K201342 · JCT | 510(k) clearances |
| May 20, 2020 | HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)K200860 · ESW | 510(k) clearances |
| Mar 7, 2019 | HANAROSTENT LowAx Colon/Rectum (NNN)K190141 · MQR | 510(k) clearances |
| Feb 11, 2019 | HANAROSTENT FASTTM Biliary (NNN)K183396 · FGE | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
