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

    Polaris RF Ablation System

    K Number: K181864 · Decision Jan 2, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    36
    Applicant Total
    24
    Review Days
    174

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    Basic Information

    Device Name
    Polaris RF Ablation System
    K Number
    K181864
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Baylis Medical Company, Inc.
    Date Received
    July 12, 2018
    Decision Date
    January 2, 2019
    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

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