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

    EZ-FIDUCIALS

    K Number: K250505 · Decision Jul 9, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    246
    Registration Numbers
    246
    Same Product Code
    417
    Applicant Total
    2
    Review Days
    138

    Basic Information

    Device Name
    EZ-FIDUCIALS
    K Number
    K250505
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Phasor Health, LLC
    Date Received
    February 21, 2025
    Decision Date
    July 9, 2025
    Product Code
    HAW
    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
    HAW Neurological Stereotaxic Instrument

    Similar 510(k) Clearances

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

    Stereotaxic Guiding Surgical Devices, NaoTrac S

    FDA 510(k)
    FDA Class 2 ·Neurology

    Navient Image Guide Navigation System (955-NC-NC), Cranial

    FDA 510(k)
    FDA Class 2 ·Neurology

    Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT

    FDA 510(k)
    FDA Class 2 ·Neurology

    ClearPoint System (Software Version 3.0)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Geniant Cranial (Navigated Neurosurgical Positioning Robot)

    FDA 510(k)
    FDA Class 2 ·Neurology

    FLASH EVD System (10-0002)

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

    Other Clearances by Phasor Health, LLC

    K Number Device Name
    K243205 EVAC