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510(k) Data Aggregation

    K Number
    K011848
    Device Name
    CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE
    Manufacturer
    CIRCON VIDEO
    Date Cleared
    2001-09-11

    (90 days)

    Product Code
    FFK
    Regulation Number
    876.4480
    Type
    Traditional
    Panel
    Gastroenterology-Urology (GU)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Circon AEH-4 Electrohydraulic Lithotripter (EHL) Probes are to be used with the Circon AEH-4 Electrohydraulic Lithotripter to fragment stones (calculi) in the urinary and biliary tracts.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for the CIRCON AEH-4 Electrohydraulic Lithotripter Probes. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about the acceptance criteria, study design, or performance data of the device.

    Therefore, I cannot provide the requested information. The letter only confirms that the device can be marketed in the US based on its substantial equivalence to previously approved devices, but it does not include details on the specific studies conducted to establish that equivalence or any performance metrics.

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