BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    Neuro Omega System; NeuroSmart System

    K Number: K250601 · Decision Mar 30, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    57
    Applicant Total
    8
    Review Days
    30

    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
    Neuro Omega System; NeuroSmart System
    K Number
    K250601
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.1330
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alpha Omega Engineering , Ltd.
    Date Received
    February 28, 2025
    Decision Date
    March 30, 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

    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

    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

    Other Clearances by Alpha Omega Engineering , Ltd.

    K Number Device Name
    K220553 Neuro Omega System, NeuroSmart System
    K191739 Sterile LeadConfirm
    K172042 NeuroNav System, NeuroSmart System
    K171581 Neuro Omega System
    K123796 NEURO OMEGA SYSTEM
    K120098 STERILE DISPOSABLES FOR MER
    K052527 NEUROPROBES