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    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Ligation Device

    K Number: K172985 · Decision Jun 14, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    21
    Applicant Total
    2
    Review Days
    260

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    Basic Information

    Device Name
    Ligation Device
    K Number
    K172985
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4400
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Leo Medical Co., Ltd.
    Date Received
    September 27, 2017
    Decision Date
    June 14, 2018
    Product Code
    FHN
    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
    FHN Ligator, Hemorrhoidal

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