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510(k) Data Aggregation

    K Number
    K050633

    Validate with FDA (Live)

    Device Name
    TRIAL CABLE RETENTION CLIP
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Date Cleared
    2005-04-21

    (41 days)

    Product Code
    GZB
    Regulation Number
    882.5880
    Type
    Special
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ANS Neurostimulation system is indicated for Spinal Cord Stimulation (SCS) in the THE ANS Frour of chronic pain of trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach.

    The Trial Cable Retention Clip is intended to be used with the ANS trial cable.

    Device Description

    Trial Cable Retention Clip

    AI/ML Overview

    I am sorry, but the provided text does not contain the necessary information to answer your request. The document is an FDA 510(k) clearance letter for a "Trial Cable Retention Clip" and primarily discusses regulatory approval, not device performance studies or acceptance criteria. It refers to the device being "substantially equivalent" to predicate devices, but does not detail specific performance metrics, study designs, or ground truth establishment.

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