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

    DISPOSABLE WET FIELD ERASER

    K Number: K880925 · Decision Apr 13, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    65
    Applicant Total
    64
    Review Days
    40

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    Basic Information

    Device Name
    DISPOSABLE WET FIELD ERASER
    K Number
    K880925
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4725
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Advanced Surgical Products, Inc.
    Date Received
    March 4, 1988
    Decision Date
    April 13, 1988
    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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