BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    LCCS Disposable RF Electrode, LCCS Reusable RF Electrode

    K Number: K152642 · Decision Aug 26, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    65
    Applicant Total
    5
    Review Days
    346

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    Basic Information

    Device Name
    LCCS Disposable RF Electrode, LCCS Reusable RF Electrode
    K Number
    K152642
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4725
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lccs Products Limited
    Date Received
    September 15, 2015
    Decision Date
    August 26, 2016
    Product Code
    GXI
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GXI Probe, Radiofrequency Lesion

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    Other Clearances by Lccs Products Limited

    K Number Device Name
    K191293 LCCS VC-S RF Cannula
    K131006 ANESTHESIA CONDUCTION NEEDLES
    K132136 SINGLE USE GROUNDING PAD
    K112231 LCCS INSULATED SPINAL NEEDLE (RF CANNULA)