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

Cleared Oct 30, 2025

HANAROSTENT Esophagus Upper (CCC)

K253327 · ESW

Gastroenterology & Urology · 30d

Cleared Nov 18, 2021

HANAROSTENT Esophagus Asymmetric (CCC)

K213251 · ESW

Gastroenterology & Urology · 49d

Cleared Jul 23, 2021

HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)

K201160 · ESW

Gastroenterology & Urology · 449d

Cleared May 11, 2021

HANAROSTENT Benefit Biliary (NNN)

K202973 · FGE

Gastroenterology & Urology · 223d

Cleared May 20, 2020

HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)

K200860 · ESW

Gastroenterology & Urology · 49d

Cleared Mar 07, 2019

HANAROSTENT LowAx Colon/Rectum (NNN)

K190141 · MQR

Gastroenterology & Urology · 37d

Cleared Feb 11, 2019

HANAROSTENT FASTTM Biliary (NNN)

K183396 · FGE

Gastroenterology & Urology · 66d

Cleared Jan 10, 2019

HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)

K183616 · MQR

Gastroenterology & Urology · 15d

Cleared Nov 02, 2018

HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus...

K180180 · MQR

Gastroenterology & Urology · 283d

Cleared Dec 30, 2011

HANAROSTENT BILIARY (NNN)

K111149 · FGE

Gastroenterology & Urology · 249d

Cleared Jun 04, 2010

HANAROSTENT ESOPHAGUS (CCC)

K093537 · ESW

Gastroenterology & Urology · 200d

Cleared Sep 25, 2008

CHOOSTENT

K072094 · ESW

Gastroenterology & Urology · 423d