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

    Relievant Medsystems RF Generator

    K Number: K171143 · Decision Aug 18, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    36
    Applicant Total
    6
    Review Days
    122

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    Basic Information

    Device Name
    Relievant Medsystems RF Generator
    K Number
    K171143
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Relievant Medsystems
    Date Received
    April 18, 2017
    Decision Date
    August 18, 2017
    Product Code
    GXD
    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
    GXD Generator, Lesion, Radiofrequency

    Similar 510(k) Clearances

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    GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03)

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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)
    K170827 INTRACEPT Intraosseous Nerve Ablation System
    K153272 INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set
    K100641 INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND EASY ACCESS INSTRUMENT SET, MODEL FG0018 (PROBE), FG0036 (INSTRUMENT SET)