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

    LAPAROLITH

    K Number: K905552 · Decision Dec 17, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    10
    Applicant Total
    505
    Review Days
    371

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    Basic Information

    Device Name
    LAPAROLITH
    K Number
    K905552
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Baxter Healthcare Corp
    Date Received
    December 11, 1990
    Decision Date
    December 17, 1991
    Product Code
    LQC
    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
    LQC Lithotriptor, Biliary Mechanical

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