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    K Number
    K240203
    Device Name
    URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor)
    Manufacturer
    DYNE Medical Group Inc.
    Date Cleared
    2024-09-05

    (224 days)

    Product Code
    FGB
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    DYNE Medical Group Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    URUS System is intended to be used by physicians to access, visualize, and perform procedures in the urinary tract and the kidney. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.
    Device Description
    The URUS System is a software-controlled single-use digital flexible ureteroscope system. That consist of the single-use digital flexible ureteroscope (DMG-SU100R) and a video processing unit (VP-100). The URUS System is intended to be used by physicians to access, visualize, and perform procedures in the urinary tract and the kidney.
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