BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    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

    K Number: K250363 · Decision Nov 5, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    57
    Applicant Total
    1
    Review Days
    268

    Basic Information

    Device Name
    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
    K Number
    K250363
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1330
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beijing Sinovation Medical Technology Co., Ltd.
    Date Received
    February 10, 2025
    Decision Date
    November 5, 2025
    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

    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

    iCE-SG2 Subcutaneous Electrode Kit

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