BEUDAMED
    FDA PMA FDA Class 2 Approved (Reclassification) 🇺🇸 United States

    Lithotriptor, Extracorporeal Shock-Wave, Urological

    PMA: P950043 · Decision Apr 7, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Lithotriptor, Extracorporeal Shock-Wave, Urological
    Trade Name
    ECONOLITH(TM) LITHOTRIPTER
    PMA Number
    P950043
    Device Class
    FDA Class 2
    Product Code
    LNS
    Generic Name
    Lithotriptor, extracorporeal shock-wave, urological
    Regulation Number
    876.5990
    Medical Specialty
    Gastroenterology, Urology
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved (Reclassification)
    Decision Code
    APRL
    Decision Date
    April 7, 1997
    Date Received
    December 26, 1995
    Expedited Review
    N
    Docket Number
    97M-0253

    Advisory Committee Statement

    APPROVAL FOR THE ECONLITH(TM) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER. THE DEVICE IS INDICATED FOR USE IN THE NON-INVASIVE FRAGMENTATION OF UPPER URINARY TRACT STONES BETWEEN 5 AND 20MM IN SIZE

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LNS Lithotriptor, Extracorporeal Shock-Wave, Urological