M.I. Tech Co., Ltd. is one of 16081 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
M.I. Tech Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: HANAROSTENT Esophagus Upper (CCC), HANAROSTENT Esophagus Asymmetric (CCC), HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)
14
Total
11
Cleared
0
Denied
M.I. Tech Co., Ltd. has 11 FDA 510(k) cleared gastroenterology & urology devices. Based in Deerfield, US.
Latest FDA clearance: Oct 2025. Active since 2008.
Browse the complete list of FDA 510(k) cleared gastroenterology & urology devices from this manufacturer. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Namsa, M.I.Tech Co., Ltd. and LK Consulting Group USA, Inc..
FDA 510(k) Regulatory Record - M.I. Tech Co., Ltd.
14 devices
Cleared
Oct 30, 2025
HANAROSTENT Esophagus Upper (CCC)
Gastroenterology & Urology
30d
Cleared
Nov 18, 2021
HANAROSTENT Esophagus Asymmetric (CCC)
Gastroenterology & Urology
49d
Cleared
Jul 23, 2021
HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)
Gastroenterology & Urology
449d
Cleared
May 11, 2021
HANAROSTENT Benefit Biliary (NNN)
Gastroenterology & Urology
223d
Cleared
Dec 31, 2020
HANAROSTENT Trachea/Bronchium (CCC)
Anesthesiology
225d
Cleared
May 20, 2020
HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)
Gastroenterology & Urology
49d
Cleared
Mar 07, 2019
HANAROSTENT LowAx Colon/Rectum (NNN)
Gastroenterology & Urology
37d
Cleared
Feb 11, 2019
HANAROSTENT FASTTM Biliary (NNN)
Gastroenterology & Urology
66d
Cleared
Jan 10, 2019
HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)
Gastroenterology & Urology
15d
Cleared
Nov 02, 2018
HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus...
Gastroenterology & Urology
283d
Cleared
Jul 27, 2016
HANAROCare ReJu
Neurology
118d
Cleared
Dec 30, 2011
HANAROSTENT BILIARY (NNN)
Gastroenterology & Urology
249d