BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Flex Robotic System and Flex Colorectal Drive

    K Number: K162330 · Decision May 4, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    111
    Applicant Total
    5
    Review Days
    258

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    Basic Information

    Device Name
    Flex Robotic System and Flex Colorectal Drive
    K Number
    K162330
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medrobotics Corporation
    Date Received
    August 19, 2016
    Decision Date
    May 4, 2017
    Product Code
    FDF
    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
    FDF Colonoscope And Accessories, Flexible/Rigid

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    Other Clearances by Medrobotics Corporation

    K Number Device Name
    K172796 Flex Robotic System and Flex Transabdominal Drive
    K170453 Medrobotics Flex Robotic System
    K172036 Medrobotics Flex Robotic System
    K150776 Medrobotics Flex System