BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SURGITEK NEPHROSTENT KIT

    K Number: K831446 · Decision Jun 22, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    121
    Applicant Total
    2
    Review Days
    48

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    Basic Information

    Device Name
    SURGITEK NEPHROSTENT KIT
    K Number
    K831446
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Mec/Surgitek Products
    Date Received
    May 5, 1983
    Decision Date
    June 22, 1983
    Product Code
    FAD
    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
    FAD Stent, Ureteral

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    Other Clearances by Mec/Surgitek Products

    K Number Device Name
    K830504 SURGITEK ULTRA-LO CUFF