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

    GUIDELINE SYSTEM

    K Number: K970943 · Decision Aug 18, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    55
    Applicant Total
    3
    Review Days
    157

    Basic Information

    Device Name
    GUIDELINE SYSTEM
    K Number
    K970943
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1330
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    AXON INSTRUMENTS, INC.
    Date Received
    March 14, 1997
    Decision Date
    August 18, 1997
    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.

    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

    Evo® sEEG System

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

    Other Clearances by AXON INSTRUMENTS, INC.

    K Number Device Name
    K990683 AXON MP-1 MICROPOSITIONER
    K971318 MM-1 MOVEMENT MONITOR