BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    T-Cuff

    K Number: K162365 · Decision Feb 16, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    107
    Registration Numbers
    107
    Same Product Code
    33
    Applicant Total
    8
    Review Days
    177

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    Basic Information

    Device Name
    T-Cuff
    K Number
    K162365
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.5910
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Terumobct, Inc.
    Date Received
    August 23, 2016
    Decision Date
    February 16, 2017
    Product Code
    KCY
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KCY Tourniquet, Pneumatic

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