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

    Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)

    K Number: K241532 · Decision Oct 22, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    97
    Applicant Total
    6
    Review Days
    145

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    Basic Information

    Device Name
    Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)
    K Number
    K241532
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shanghai SeeGen Photoelectric Technology Co., Ltd.
    Date Received
    May 30, 2024
    Decision Date
    October 22, 2024
    Product Code
    FET
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology

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    Other Clearances by Shanghai SeeGen Photoelectric Technology Co., Ltd.

    K Number Device Name
    K252457 Disposable Distal End Tape Hood
    K243535 Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)
    K222499 Disposable Endoscope Valves Kit
    K222261 Flexible Video-Choledochoscope System
    K211686 Flexible Video-Choledo-Cysto-Ureteroscope System