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M.I.Tech Co., Ltd.

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories5
Latest FDA decision2025-10-30
TypeNumberDevice NameCodeDateActions
510(k) K253327 HANAROSTENT Esophagus Upper (CCC)ESW2025-10-30 View
510(k) K213251 HANAROSTENT Esophagus Asymmetric (CCC)ESW2021-11-18 View
510(k) K201160 HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)ESW2021-07-23 View
510(k) K202973 HANAROSTENT Benefit Biliary (NNN)FGE2021-05-11 View
510(k) K201342 HANAROSTENT Trachea/Bronchium (CCC)JCT2020-12-31 View
510(k) K200860 HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)ESW2020-05-20 View
510(k) K190141 HANAROSTENT LowAx Colon/Rectum (NNN)MQR2019-03-07 View
510(k) K183396 HANAROSTENT FASTTM Biliary (NNN)FGE2019-02-11 View
510(k) K183616 HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)MQR2019-01-10 View
510(k) K180180 HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)MQR2018-11-02 View
510(k) K160893 HANAROCare ReJuNUH2016-07-27 View
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