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

    Zeta Navigation System (ZNS131-US)

    K Number: K251927 · Decision Oct 10, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    4
    Review Days
    109

    Basic Information

    Device Name
    Zeta Navigation System (ZNS131-US)
    K Number
    K251927
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zeta Surgical, Inc.
    Date Received
    June 23, 2025
    Decision Date
    October 10, 2025
    Product Code
    SGE
    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
    SGE Extracranial Positional System For A Transcranial Magnetic Stimulation System

    Other Clearances by Zeta Surgical, Inc.

    K Number Device Name
    K253663 Zeta Navigation System
    K242351 Zeta Cranial Navigation System (ZNS131-US)
    K233903 Zeta Cranial Navigation System (ZNS131-US)