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510(k) Data Aggregation

    K Number
    K061259
    Device Name
    MODIFICATION TO ARTHROCARE PERC-D SPINEWAND
    Manufacturer
    ARTHROCARE CORP.
    Date Cleared
    2006-05-18

    (13 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K053447
    Why did this record match?
    Device Name :

    MODIFICATION TO ARTHROCARE PERC-D SPINEWAND

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

    The Perc-D™ SpineWand™ is indicated for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated discs.

    Device Description

    The Wands are bipolar, single use, high frequency electrosurgical devices.

    AI/ML Overview

    I am sorry, but the provided text does not contain any information regarding acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) summary and an FDA clearance letter for the ArthroCare® Perc-D™ SpineWand™. It discusses the device's labeling and substantial equivalence to a predicate device, but not performance studies with specific metrics.

    Therefore, I cannot provide the requested information in the format specified because the necessary data is not present in the input.

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