BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE

    K Number: K071745 · Decision Jul 19, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    65
    Applicant Total
    28
    Review Days
    22

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    Basic Information

    Device Name
    BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE
    K Number
    K071745
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.4725
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Baylis Medical Co., Inc.
    Date Received
    June 27, 2007
    Decision Date
    July 19, 2007
    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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    K101372 DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20
    K101615 POWERWIRE RADIOFREQUENCY GUIDEWIRE
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    K092877 INDISCAL ASPIRATION DEVICE AND ACCESSORIES
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    K073326 NRG TRANSSEPTAL NEEDLE
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