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510(k) Data Aggregation

    K Number
    K171024
    Device Name
    ShockPulse-SE Lithotripsy System
    Manufacturer
    Cybersonics, Inc.
    Date Cleared
    2017-08-21

    (138 days)

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

    Cybersonics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ShockPulse-SE Lithotripsy System is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter and bladder.
    Device Description
    The ShockPulse-SE Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse-SE Lithotripsy System consists of generator, probes, transducer, cleaning stylet, wrench, power cord and nosecone. Footswitch is optional.
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    K Number
    K142428
    Device Name
    Shock Pulse-SE Lithotripsy System CYBERWAND II
    Manufacturer
    CYBERSONICS, INC.
    Date Cleared
    2014-11-13

    (76 days)

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

    CYBERSONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ShockPulse-SE Lithotripsy System is intended to be used for the fragmentation of urinary tract calcul in the kidney, ureter and bladder.
    Device Description
    The ShockPulse-SE Lithotripsy System (CYBERWAND II) is the next generation of the CyberWand System. The ShockPulse-SE is an electromechanical device, whose intended purpose is to fragment and aspirate calculi. The hand piece consists of an ultrasonic transducer containing piezoelectric elements which are driven by a generator operating at approximately 21,000 Hz. The transducer is lightweight and incorporates two contact switches that activate Standard Power and High Power generator output. Activation will either require continuous pushing of the button or a double click to latch activation on; a single click of either button would then turn activation off. There are markings near the buttons to indicate function. Suction control is integrated into the transducer housing. With a thumb wheel that can rotate approximately 20 degrees, the flow can be varied from "full" on to "off." There are markings on the transducer to indicate which direction increases and decreases suction flow through the transducer lumen. There are families of probes that function similar to the probes of the current CyberWand System (K120303) by transmitting stress-waves from the transducer to the calculi to break up kidney-stones. Hollow probes permit simultaneous suction. The direct patient-contact material is stainless steel, which is the same material used in the predicate system.
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    K Number
    K132795
    Device Name
    CYBERWAND STERILE PROBE SET
    Manufacturer
    CYBERSONICS, INC.
    Date Cleared
    2013-11-26

    (81 days)

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

    CYBERSONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CyberWand Sterile Probe Set is designed to be used only with the CyberWand Dual Action Ultrasonic Lithotripsy System for the fragmentation of urinary tract calculi in the kidneys, ureter, and bladder.
    Device Description
    The Cybersonics CyberWand Dual Probe Ultrasonic Lithotripsy System is an electromechanical device capable of fragmenting and aspirating calculi. The hand piece consists of an ultrasonic transducer containing the piezoelectric elements. which are driven by a generator operating at 20400 - 22200 Hz. The resulting longitudinal waves are propagated along the ultrasonic dual probe to the target stone. The ultrasonic transducer probes are hollow, permitting simultaneous suction.
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    K Number
    K120303
    Device Name
    CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM
    Manufacturer
    CYBERSONICS, INC.
    Date Cleared
    2012-06-05

    (125 days)

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

    CYBERSONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CyberWand Dual Action Ultrasonic Lithotripsy System is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter and bladder.
    Device Description
    The CyberWand Dual Action Ultrasonic Lithotripsy System includes a Generator, Transducer (2), Footswitch, Power Cord, Wrench, and Cleaning Stylet. The disposable probe set is sold separately either sterile or non-sterile. The Cybersonics CyberWand Dual Probe Ultrasonic Lithotripsy System is an electromechanical device capable of fragmenting and aspirating calculi. The hand piece consists of an ultrasonic transducer containing the piezoelectric elements, which are driven by a generator operating at 20400 - 22200 Hz. The resulting longitudinal waves are propagated along the ultrasonic dual probe to the target stone. The ultrasonic transducer probes are hollow, permitting simultaneous suction.
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    K Number
    K102169
    Device Name
    CYBERWAND LITHOTRIPTER
    Manufacturer
    CYBERSONICS, INC.
    Date Cleared
    2010-08-30

    (28 days)

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

    CYBERSONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CyberWand Hollow Semi-Flexible Ureteral probe is designed to be used only with the CyberWand System for the fragmentation of urinary tract calculi in the kidneys, ureter, and bladder.
    Device Description
    The CyberWand Dual Ultrasonic Lithotripsy System is an electromechanical device used to fragment and aspirate calculi. The system consists of the generator unit, transducer handpiece, footswitch, probe sets and cleaning stylets. The Semi-Flexible Probe is constructed entirely of stainless steel and is packaged with a stainless steel cleaning stylet. The probe has a working length of 58.5 cm and an outer diameter of 1.65 mm; it is is intended to be used primarily with semi-rigid or ridged scopes (cystoscopes, nephroscopes and ureteroscopes) which have a working channel between 5 and 7 French in diameter. The probe is for provided non-sterile and is for single-patient use.
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    K Number
    K072422
    Device Name
    CYBERWAND STERILE PADS, MODEL: CW-RBPBX
    Manufacturer
    CYBERSONICS, INC.
    Date Cleared
    2007-10-24

    (57 days)

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

    CYBERSONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CyberWand™ Lithotripter with STERILE Probes is intended to be used for the intracorporeal fragmentation of urinary tract calculi in the kidney, ureter, bladder and biliary tracts.
    Device Description
    Not Found
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    K Number
    K052135
    Device Name
    CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER
    Manufacturer
    CYBERSONICS, INC.
    Date Cleared
    2005-12-20

    (137 days)

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

    CYBERSONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cyberwand Dual Probe Lithotripter is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter and bladder.
    Device Description
    The Cybersonics, Cyberwand Dual Probe Ultrasonic Lithotripsy system is an electromechanical device capable of fragmenting and aspirating calculi. The hand piece consists of an ultrasonic transducer containing the piezo-electronic elements, which are driven by a generator operating at 21 ± 1 kHz. The resulting longitudinal waves are propagated along the ultrasonic dual probe to the target stone. The ultrasonic transducer probes are hollow, permitting simultaneous suction.
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