M.I.Tech Co., Ltd.

Medical device manufacturer in Pyeongtaek-Si, Gyeonggi-Do, KR.

14510(k) clearances
0PMA approvals
0recalls

Device types

510(k) clearances

510(k)DeviceDecision
K253327HANAROSTENT Esophagus Upper (CCC)ESW · Special 10/30/2025SE
K213251HANAROSTENT Esophagus Asymmetric (CCC)ESW · Special 11/18/2021SE
K201160HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)ESW · Traditional 07/23/2021SE
K202973HANAROSTENT Benefit Biliary (NNN)FGE · Traditional 05/11/2021SESU
K201342HANAROSTENT Trachea/Bronchium (CCC)JCT · Traditional 12/31/2020SE
K200860HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)ESW · Traditional 05/20/2020SE
K190141HANAROSTENT LowAx Colon/Rectum (NNN)MQR · Special 03/07/2019SE
K183396HANAROSTENT FASTTM Biliary (NNN)FGE · Traditional 02/11/2019SESU
K183616HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)MQR · Traditional 01/10/2019SE
K180180HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)MQR · Traditional 11/02/2018SE
K160893HANAROCare ReJuNUH · Traditional 07/27/2016SE
K111149Hanarostent Biliary (NNN)FGE · Traditional 12/30/2011SESU
K093537Hanarostent Esophagus (CCC)ESW · Special 06/04/2010SE
K072094ChoostentESW · Traditional 09/25/2008SE