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

    Flex Robotic System and Flex Transabdominal Drive

    K Number: K172796 · Decision Jan 18, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    153
    Registration Numbers
    153
    Same Product Code
    337
    Applicant Total
    5
    Review Days
    125

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    Basic Information

    Device Name
    Flex Robotic System and Flex Transabdominal Drive
    K Number
    K172796
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1720
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medrobotics Corporation
    Date Received
    September 15, 2017
    Decision Date
    January 18, 2018
    Product Code
    HET
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HET Laparoscope, Gynecologic (And Accessories)

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    Other Clearances by Medrobotics Corporation

    K Number Device Name
    K170453 Medrobotics Flex Robotic System
    K172036 Medrobotics Flex Robotic System
    K162330 Flex Robotic System and Flex Colorectal Drive
    K150776 Medrobotics Flex System