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

    NICOLET CORTICAL STIMULATOR

    K Number: K072964 · Decision Dec 30, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    31
    Applicant Total
    26
    Review Days
    438

    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
    NICOLET CORTICAL STIMULATOR
    K Number
    K072964
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    882.1310
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardinal Health, Inc.
    Date Received
    October 19, 2007
    Decision Date
    December 30, 2008
    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 Cardinal Health, Inc.

    K Number Device Name
    K170198 Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White)
    K160411 Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating
    K160875 Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating
    K153316 Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow)
    K122696 POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE)
    K121897 PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES
    K120934 PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOVE WITH PROTEIN CONTENT LABEL CLAIM OF 50 UG/DM OR LESS
    K111878 PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES
    K110272 STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUG
    K111015 STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATING
    Search all 26 clearances from Cardinal Health, Inc. →