BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    HJY VisualNext 3D Endoscopic Vision System

    K Number: K243429 · Decision May 21, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    90
    Applicant Total
    2
    Review Days
    197

    Basic Information

    Device Name
    HJY VisualNext 3D Endoscopic Vision System
    K Number
    K243429
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1480
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    HJY Smart Medical Device Co., Ltd.
    Date Received
    November 5, 2024
    Decision Date
    May 21, 2025
    Product Code
    GWG
    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
    GWG Endoscope, Neurological

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    Other Clearances by HJY Smart Medical Device Co., Ltd.

    K Number Device Name
    K222735 HJY VisualNext Endoscopic Vision System