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

    BARD 4-WIRE URETEROSCOPIC STONE

    K Number: K921233 · Decision Apr 27, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    51
    Applicant Total
    566
    Review Days
    45

    Basic Information

    Device Name
    BARD 4-WIRE URETEROSCOPIC STONE
    K Number
    K921233
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4680
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    C.R. BARD, INC.
    Date Received
    March 13, 1992
    Decision Date
    April 27, 1992
    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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