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

    Phantom XL Insulated Dilators

    K Number: K231691 · Decision Jun 29, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    52
    Applicant Total
    1
    Review Days
    20

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Phantom XL Insulated Dilators
    K Number
    K231691
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.1350
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    TeDan Surgical Innovations, Inc.
    Date Received
    June 9, 2023
    Decision Date
    June 29, 2023
    Product Code
    GXZ
    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
    GXZ Electrode, Needle

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GXZ), ordered by most recent decision date.

    Disposable Subdermal Needle Electrode, Corkscrew

    FDA 510(k)
    FDA Class 2 ·Neurology

    Medical Disposable Sterile Needle Electrode

    FDA 510(k)
    FDA Class 2 ·Neurology

    Guardian Needle Electrode

    FDA 510(k)
    FDA Class 2 ·Neurology

    Spes Medica Subdermal Needle Electrodes

    FDA 510(k)
    FDA Class 2 ·Neurology

    PressOn Electrode Headset

    FDA 510(k)
    FDA Class 2 ·Neurology

    DMS Disposable Subdermal Needle Electrodes

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all