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510(k) Data Aggregation

    K Number
    K972846
    Device Name
    BMC RF CANNULA
    Manufacturer
    BAYLIS MEDICAL CO., INC.
    Date Cleared
    1998-07-17

    (350 days)

    Product Code
    GXI
    Regulation Number
    882.4725
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BMC RF CANNULA

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

    The BMC RF Cannula is intended for use in radio-frequency (RF) Heat lesion procedures for relief of pain.

    Device Description

    BMC RF Cannula

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving device performance. The document is a 510(k) clearance letter from the FDA for the BMC RF Cannula, indicating that the device is substantially equivalent to a predicate device for its stated indications for use in radio-frequency (RF) heat lesion procedures for pain relief.

    Therefore, I cannot provide the requested table or answer the specific questions about studies, sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided text.

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