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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Esophageal
510(k) Number K253327
Device Name HANAROSTENT Esophagus Upper (CCC)
Applicant
M.I.Tech Co., Ltd.
174 Habuk 2-Gil, Jinwi-Myeon,
Pyeongtaek-Si, Gyeonggi-Do,  KR 17706
Applicant Contact Jeongeun Park
Correspondent
Namsa
381 Lark Ln.
Bailey,  CO  80421
Correspondent Contact Monica Montanez
Regulation Number878.3610
Classification Product Code
ESW  
Date Received09/30/2025
Decision Date 10/30/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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