Medical Device Manufacturer · US , Deerfield , IL

M.I. Tech Co., Ltd. - FDA 510(k) Cleared Devices

14 submissions · 11 cleared · Since 2008

Recent clearances: HANAROSTENT Esophagus Upper (CCC), HANAROSTENT Esophagus Asymmetric (CCC), HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)

14

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - M.I. Tech Co., Ltd. Gastroenterology & Urology ✕

12 devices

1-12 of 12

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 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 Dec 30, 2011

HANAROSTENT BILIARY (NNN)

Gastroenterology & Urology · 249d

Cleared Jun 04, 2010

HANAROSTENT ESOPHAGUS (CCC)

Gastroenterology & Urology · 200d

Cleared Sep 25, 2008

Gastroenterology & Urology · 423d