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

    PHYSICIAN INDUSTRIES RADIOFREQUENCY ABLATION NEEDLE

    K Number: K040565 · Decision Jul 22, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    36
    Applicant Total
    4
    Review Days
    141

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    Basic Information

    Device Name
    PHYSICIAN INDUSTRIES RADIOFREQUENCY ABLATION NEEDLE
    K Number
    K040565
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Physician Industries, Inc.
    Date Received
    March 3, 2004
    Decision Date
    July 22, 2004
    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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    Other Clearances by Physician Industries, Inc.

    K Number Device Name
    K033739 PHYSICIAN INDUSTRIES' DURAMETER SYRINGE
    K960248 GENERAL PROCEDURE KIT
    K954068 GENERAL HYGIENE KIT