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510(k) Data Aggregation

    K Number
    K033335
    Device Name
    LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS
    Date Cleared
    2003-11-25

    (40 days)

    Product Code
    Regulation Number
    876.4890
    Why did this record match?
    Product Code :

    MMZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    LITHOSTAR Modularis with Shockwave System Coplis is a urologic procedures system which can be used for a wide range of applications. It is a transportable system. The system is capable of both diagnostic and therapeutic procedures of urolithiasis in the kidney and upper ureter. The primary use of this device is for the fragmentation of urinary tract stones, i.e. renal calyceal stones, renal pelvis stones, and upper ureteral stones by extracorporeal shock wave lithotripsy (ESWL). In addition to ESWL use, the unit is designed for patient placement in positions which facilitate urological and diagnostic procedures.
    Device Description
    Siemens LITHOSTAR MODULARIS with Shockwave System Collis is a modification to our predicate device. The shockwave head has been modified to provide an increased penetration depth for a more obese patient population. The penetration depth has been increased from 120mm to 140mm..
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