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

    LCCS INSULATED SPINAL NEEDLE (RF CANNULA)

    K Number: K112231 · Decision Aug 19, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    65
    Applicant Total
    5
    Review Days
    15

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    Basic Information

    Device Name
    LCCS INSULATED SPINAL NEEDLE (RF CANNULA)
    K Number
    K112231
    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
    August 4, 2011
    Decision Date
    August 19, 2011
    Product Code
    GXI
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    Y

    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
    K152642 LCCS Disposable RF Electrode, LCCS Reusable RF Electrode
    K131006 ANESTHESIA CONDUCTION NEEDLES
    K132136 SINGLE USE GROUNDING PAD