510(k) K253327

HANAROSTENT Esophagus Upper (CCC) by M.I.Tech Co., Ltd. — Product Code ESW

K253327 is an FDA 510(k) premarket notification submitted by M.I.Tech Co., Ltd. for the device "HANAROSTENT Esophagus Upper (CCC)". The FDA issued a decision of Substantially Equivalent on October 30, 2025. The device falls under product code ESW (Prosthesis, Esophageal), a Class II device regulated under 21 CFR 878.3610. M.I.Tech Co., Ltd. has at least 10 other 510(k) clearances on record.