BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor)

    K Number: K240203 · Decision Sep 5, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    120
    Registration Numbers
    120
    Same Product Code
    112
    Applicant Total
    2
    Review Days
    224

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    Basic Information

    Device Name
    URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor)
    K Number
    K240203
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dyne Medical Group, Inc.
    Date Received
    January 25, 2024
    Decision Date
    September 5, 2024
    Product Code
    FGB
    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
    FGB Ureteroscope And Accessories, Flexible/Rigid

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    Other Clearances by Dyne Medical Group, Inc.

    K Number Device Name
    K252933 DYNE PORT