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

    HANAROSTENT Benefit Biliary (NNN)

    K Number: K202973 · Decision May 11, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    473
    Applicant Total
    14
    Review Days
    223

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    Basic Information

    Device Name
    HANAROSTENT Benefit Biliary (NNN)
    K Number
    K202973
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    M.I.Tech Co., Ltd.
    Date Received
    September 30, 2020
    Decision Date
    May 11, 2021
    Product Code
    FGE
    Advisory Committee
    Gastroenterology, Urology
    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
    FGE Stents, Drains And Dilators For The Biliary Ducts

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

    K Number Device Name
    K253327 HANAROSTENT Esophagus Upper (CCC)
    K213251 HANAROSTENT Esophagus Asymmetric (CCC)
    K201160 HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)
    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. →