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510(k) Data Aggregation

    K Number
    K032196
    Device Name
    NBD DISPOSABLE RF CANNULAE
    Manufacturer
    NEW BUSINESS DEVELOPMENT, LLC
    Date Cleared
    2003-10-09

    (83 days)

    Product Code
    GXI,GXD
    Regulation Number
    882.4725
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The NBD Disposable RF Needle are indicated for use in radio frequency heat lesion procedures for relief of pain.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the "NBD Disposable RF Needle." It confirms substantial equivalence to a predicate device and allows the marketing of the device. However, it does not contain any information about acceptance criteria, device performance, study details, ground truth establishment, or sample sizes related to AI or algorithm performance studies.

    Therefore, I cannot provide the requested information. The document focuses on regulatory clearance, not on the technical performance data of the device itself in the context of a study.

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