Medical Device Manufacturer · US , Deerfield , IL

M.I. Tech Co., Ltd.

14 submissions · 11 cleared · Since 2008
14
Total
11
Cleared
0
Denied

M.I. Tech Co., Ltd. — FDA 510(k) Submissions

M.I. Tech Co., Ltd. has submitted 14 FDA 510(k) premarket notifications since 2008, of which 11 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Prosthesis, Esophageal, Stents, Drains And Dilators For The Biliary Ducts, Stent, Colonic, Metallic, Expandable, Stimulator, Nerve, Transcutaneous, Over-the-counter, Prosthesis, Tracheal, Expandable . Use the specialty filter in the sidebar to narrow results.

14 devices
1–14 of 14
HANAROSTENT Esophagus Upper (CCC)
K253327 · ESW Prosthesis, Esophageal · Gastroenterology & Urology
Oct 2025 30d
HANAROSTENT Esophagus Asymmetric (CCC)
K213251 · ESW Prosthesis, Esophageal · Gastroenterology & Urology
Nov 2021 49d
HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)
K201160 · ESW Prosthesis, Esophageal · Gastroenterology & Urology
Jul 2021 449d
HANAROSTENT Benefit Biliary (NNN)
K202973 · FGE Stents, Drains And... · Gastroenterology & Urology
May 2021 223d
HANAROSTENT Trachea/Bronchium (CCC)
K201342 · JCT Prosthesis, Tracheal,... · Anesthesiology
Dec 2020 225d
HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)
K200860 · ESW Prosthesis, Esophageal · Gastroenterology & Urology
May 2020 49d
HANAROSTENT LowAx Colon/Rectum (NNN)
K190141 · MQR Stent, Colonic, Metallic,... · Gastroenterology & Urology
Mar 2019 37d
HANAROSTENT FASTTM Biliary (NNN)
K183396 · FGE Stents, Drains And... · Gastroenterology & Urology
Feb 2019 66d
HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)
K183616 · MQR Stent, Colonic, Metallic,... · Gastroenterology & Urology
Jan 2019 15d
HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)
K180180 · MQR Stent, Colonic, Metallic,... · Gastroenterology & Urology
Nov 2018 283d
HANAROCare ReJu
K160893 · NUH Stimulator, Nerve,... · Neurology
Jul 2016 118d
HANAROSTENT BILIARY (NNN)
K111149 · FGE Stents, Drains And... · Gastroenterology & Urology
Dec 2011 249d
HANAROSTENT ESOPHAGUS (CCC)
K093537 · ESW Prosthesis, Esophageal · Gastroenterology & Urology
Jun 2010 200d
CHOOSTENT
K072094 · ESW Prosthesis, Esophageal · Gastroenterology & Urology
Sep 2008 423d
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