M.I.Tech Co., Ltd. FDA Approvals

0 new drug approvals and 4 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
HANAROSTENT Esophagus Upper (CCC)510(k)Oct 30, 2025General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Special)	Oct 30, 2025
HANAROSTENT Esophagus Asymmetric (CCC)510(k)Nov 18, 2021General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Special)	Nov 18, 2021
HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)510(k)Jul 23, 2021General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Jul 23, 2021
HANAROSTENT Benefit Biliary (NNN)510(k)May 11, 2021Gastroenterology, Urology	Gastroenterology, Urology	510(k)Unknown (Traditional)	May 11, 2021