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

    NaviCam Capsule Endoscope System with NaviCam Stomach Capsule

    K Number: DEN190037 · Decision May 22, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    283

    Basic Information

    Device Name
    NaviCam Capsule Endoscope System with NaviCam Stomach Capsule
    K Number
    DEN190037
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    876.1310
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Applicant
    AnX Robotica, Inc.
    Date Received
    August 13, 2019
    Decision Date
    May 22, 2020
    Product Code
    QKZ
    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
    QKZ Magnetically Maneuvered Capsule Endoscopy System

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