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510(k) Data Aggregation

    K Number
    K162119
    Device Name
    UreTron PF Series Probe
    Manufacturer
    MED-SONICS CORP.
    Date Cleared
    2016-08-29

    (28 days)

    Product Code
    FFK
    Regulation Number
    876.4480
    Why did this record match?
    Applicant Name (Manufacturer) :

    MED-SONICS CORP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UreTron PF Series Probes are to be used with UreTron Multi Probe Lithotripsy System. UreTron Multi Probe Lithotripter System is intended for the fragmentation and removal of urinary tract calculi in the kidney, ureter, and bladder.
    Device Description
    Not Found
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    K Number
    K160198
    Device Name
    UreTron MultiProbe Lithotripter System
    Manufacturer
    Med-Sonics Corp
    Date Cleared
    2016-02-23

    (26 days)

    Product Code
    FFK
    Regulation Number
    876.4480
    Why did this record match?
    Applicant Name (Manufacturer) :

    Med-Sonics Corp

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UreTron Multi Probe Lithotripter System is intended for the fragmentation and removal of urinary tract calculi in the kidney, ureter, and bladder.
    Device Description
    Not Found
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    K Number
    K111058
    Device Name
    URETRON MODEL URT
    Manufacturer
    MED-SONICS CORP
    Date Cleared
    2012-03-30

    (347 days)

    Product Code
    FFK
    Regulation Number
    876.4480
    Why did this record match?
    Applicant Name (Manufacturer) :

    MED-SONICS CORP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UreTron Multi Probe Lithotripter system is intended to be used for the fragmentation and removal of urinary tract calculi in the kidney, ureter and bladder.
    Device Description
    The UreTron Multi Probe Lithotripter system is intended to be used for the fragmentation and removal of urinary tract calculi in the kidney, ureter and bladder. The system is an electromechanical device and consists of a generator, hand piece and probes. The hand piece is an ultrasonic transducer containing piezo-electric ceramic elements. The generator drives the hand piece at 21000 +/- 1000 Hz to get mechanical vibration through the probes to urinary tract calculi.
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