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

    Neurolyser XR (NXR100)

    K Number: DEN250015 · Decision Nov 14, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    203

    Basic Information

    Device Name
    Neurolyser XR (NXR100)
    K Number
    DEN250015
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    882.4420
    Medical Specialty
    Neurology
    Decision
    Unknown
    Applicant
    Fusmobile, Inc.
    Date Received
    April 25, 2025
    Decision Date
    November 14, 2025
    Product Code
    SGN
    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
    SGN High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation