BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set

    K Number: K153272 · Decision Jul 9, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    65
    Applicant Total
    6
    Review Days
    240

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    Basic Information

    Device Name
    INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set
    K Number
    K153272
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4725
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Relievant Medsystems
    Date Received
    November 12, 2015
    Decision Date
    July 9, 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 Relievant Medsystems

    K Number Device Name
    K190504 Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator
    K180369 Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)
    K171143 Relievant Medsystems RF Generator
    K170827 INTRACEPT Intraosseous Nerve Ablation System
    K100641 INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND EASY ACCESS INSTRUMENT SET, MODEL FG0018 (PROBE), FG0036 (INSTRUMENT SET)