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

    AD-TECH SUB DURAL ELECTRODEDS

    K Number: K923803 · Decision Oct 23, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    31
    Applicant Total
    18
    Review Days
    86

    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
    AD-TECH SUB DURAL ELECTRODEDS
    K Number
    K923803
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1310
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ad-Tech Medical Instrument Corp
    Date Received
    July 29, 1992
    Decision Date
    October 23, 1992
    Product Code
    GYC
    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
    GYC Electrode, Cortical

    Similar 510(k) Clearances

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

    Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Layer 7-T

    FDA 510(k)
    FDA Class 2 ·Neurology

    WISE Cortical Strip (WCS)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid

    FDA 510(k)
    FDA Class 2 ·Neurology

    Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)

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

    Other Clearances by Ad-Tech Medical Instrument Corp

    K Number Device Name
    K112094 BRAIN BIOPSY NEEDLE
    K053363 DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES
    K053358 DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES
    K041604 MACRO-MICRO DEPTH ELECTRODE
    K990788 AD-TECH'S FORAMEN OVALE ELECTRODE
    K992194 CORTICAL MAPPING UNIT, MODEL CMU
    K973454 AD-TECH'S SPINAL ELECTRODE
    K970587 AD-TECH SUBDURAL ELECTRODE
    K964644 AD-TECH'S DEPTH ELECTRODE
    K940320 AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS
    Search all 18 clearances from Ad-Tech Medical Instrument Corp →