BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    HANAROSTENT Esophagus Upper (CCC)

    K Number: K253327 · Decision Oct 30, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    58
    Applicant Total
    14
    Review Days
    30

    Basic Information

    Device Name
    HANAROSTENT Esophagus Upper (CCC)
    K Number
    K253327
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.3610
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    M.I.Tech Co., Ltd.
    Date Received
    September 30, 2025
    Decision Date
    October 30, 2025
    Product Code
    ESW
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ESW Prosthesis, Esophageal

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    Other Clearances by M.I.Tech Co., Ltd.

    K Number Device Name
    K213251 HANAROSTENT Esophagus Asymmetric (CCC)
    K201160 HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)
    K202973 HANAROSTENT Benefit Biliary (NNN)
    K201342 HANAROSTENT Trachea/Bronchium (CCC)
    K200860 HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)
    K190141 HANAROSTENT LowAx Colon/Rectum (NNN)
    K183396 HANAROSTENT FASTTM Biliary (NNN)
    K183616 HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)
    K180180 HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)
    K160893 HANAROCare ReJu
    Search all 14 clearances from M.I.Tech Co., Ltd. →