BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)

    K Number: K250551 · Decision Oct 2, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    2
    Review Days
    219

    Basic Information

    Device Name
    4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)
    K Number
    K250551
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Sophway Technology Co., Ltd.
    Date Received
    February 25, 2025
    Decision Date
    October 2, 2025
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Shenzhen Sophway Technology Co., Ltd.

    K Number Device Name
    K250204 Endoscopic Camera System