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

    SURGIPRESS SURGICAL LOOP

    K Number: K843593 · Decision Oct 24, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    182
    Registration Numbers
    182
    Same Product Code
    14
    Applicant Total
    10
    Review Days
    42

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    Basic Information

    Device Name
    SURGIPRESS SURGICAL LOOP
    K Number
    K843593
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Syntex Corp.
    Date Received
    September 12, 1984
    Decision Date
    October 24, 1984
    Product Code
    HRQ
    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
    HRQ Hemostat

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