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

    Auris Robotic Endoscopy System (ARES)

    K Number: K152319 · Decision May 26, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    238
    Applicant Total
    2
    Review Days
    283

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    Basic Information

    Device Name
    Auris Robotic Endoscopy System (ARES)
    K Number
    K152319
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4680
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Auris Surgical Robotics, Inc.
    Date Received
    August 17, 2015
    Decision Date
    May 26, 2016
    Product Code
    EOQ
    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
    EOQ Bronchoscope (Flexible Or Rigid)

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    Other Clearances by Auris Surgical Robotics, Inc.

    K Number Device Name
    K173760 Monarch Endoscopy Platform (Monarch Platform)