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

    HANAROSTENT FASTTM Biliary (NNN)

    K Number: K183396 · Decision Feb 11, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    473
    Applicant Total
    14
    Review Days
    66

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    Basic Information

    Device Name
    HANAROSTENT FASTTM Biliary (NNN)
    K Number
    K183396
    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
    December 7, 2018
    Decision Date
    February 11, 2019
    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.

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    K202973 HANAROSTENT Benefit Biliary (NNN)
    K201342 HANAROSTENT Trachea/Bronchium (CCC)
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