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

    Medrobotics Flex Robotic System

    K Number: K170453 · Decision Oct 19, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    161
    Applicant Total
    5
    Review Days
    246

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    Basic Information

    Device Name
    Medrobotics Flex Robotic System
    K Number
    K170453
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4760
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medrobotics Corporation
    Date Received
    February 15, 2017
    Decision Date
    October 19, 2017
    Product Code
    EOB
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EOB Nasopharyngoscope (Flexible Or Rigid)

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    Other Clearances by Medrobotics Corporation

    K Number Device Name
    K172796 Flex Robotic System and Flex Transabdominal Drive
    K172036 Medrobotics Flex Robotic System
    K162330 Flex Robotic System and Flex Colorectal Drive
    K150776 Medrobotics Flex System