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

    RECORDING AND STIMULATING ELECTRODE

    K Number: K012850 · Decision Nov 19, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    57
    Applicant Total
    8
    Review Days
    87

    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
    RECORDING AND STIMULATING ELECTRODE
    K Number
    K012850
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1330
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Radionics, A Division of Tyco Healthcare Group LP
    Date Received
    August 24, 2001
    Decision Date
    November 19, 2001
    Product Code
    GZL
    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
    GZL Electrode, Depth

    Similar 510(k) Clearances

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

    Wovyn Depth Electrode

    FDA 510(k)
    FDA Class 2 ·Neurology

    Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth Electrode (RSDE-14); Depth Electrode (RSDE-16); Depth Electrode (RSDE-16F); Depth Electrode (RSDE-08S); Depth Electrode (RSDE-10S); Depth Electrode (RSDE-12S); Depth Electrode (RSDE-14S); Depth Electrode (RSDE-16S); Depth Electrode (RSDE-16G); Depth Electrode (RSDE-18); Depth Electrode (RSDE-18F); Depth Electrode (RSDE-18T); Depth Electrode (RSDE-20); Depth Electrode (RSDE-20F); Dept

    FDA 510(k)
    FDA Class 2 ·Neurology

    Neuro Omega System; NeuroSmart System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Anchor Bolts as Accessories to Depth Electrodes

    FDA 510(k)
    FDA Class 2 ·Neurology

    Spencer Probe Depth Electrodes

    FDA 510(k)
    FDA Class 2 ·Neurology

    SENSOSEEG Depth Electrodes

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

    Other Clearances by Radionics, A Division of Tyco Healthcare Group LP

    K Number Device Name
    K051947 RADIONICS CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE
    K041997 RADIONICS XKNIFE RT 3 WITH NON STEREOTACTIC MODULE
    K032054 RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE
    K023519 RADIONICS VARILINK 2
    K021942 RADIONICS POLE NEEDLES
    K013661 XPLAN 2.2 WITH THE BODY SYSTEM
    K010548 MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)