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510(k) Data Aggregation

    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
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CYBERWAND STERILE PADS, MODEL: CW-RBPBX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the CyberWand™ Lithotripter with STERILE Probes. It states that the device is substantially equivalent to legally marketed predicate devices, but it does not contain any information about specific acceptance criteria or a study proving the device meets particular performance metrics.

    The letter focuses on the regulatory approval process based on substantial equivalence, rather than detailing the results of performance studies against pre-defined acceptance criteria. Therefore, I cannot extract the requested information from this document.

    To answer your request, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a comprehensive 510(k) submission that includes performance data.

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