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

    BALLOON DILATION HELICAL STONE EXTRACT

    K Number: K831875 · Decision Sep 12, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    51
    Applicant Total
    2
    Review Days
    91

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    Basic Information

    Device Name
    BALLOON DILATION HELICAL STONE EXTRACT
    K Number
    K831875
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4680
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Vpi
    Date Received
    June 13, 1983
    Decision Date
    September 12, 1983
    Product Code
    FFL
    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
    FFL Dislodger, Stone, Basket, Ureteral, Metal

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    Other Clearances by Vpi

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