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510(k) Data Aggregation

    K Number
    K982902
    Device Name
    PERIPHERAL NERVE STIMULATION
    Manufacturer
    MEDTRONIC VASCULAR
    Date Cleared
    1998-11-10

    (88 days)

    Product Code
    GZF
    Regulation Number
    882.5870
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    K011702,K190047
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Peripheral nerve stimulate electrically a peripheral nerve in patients to relieve severe intractable pain. In order to maintain consistency between products, this indication will be used for all Medicated devices.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a Peripheral Nerve Stimulator for Pain. It outlines the regulatory approval for marketing the device based on substantial equivalence to predicate devices.

    However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The letter is a regulatory approval, not a technical report detailing the performance evaluation of the device.

    Therefore, I cannot provide the requested information from the given input.

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