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

    IntraMarX 3D Radiopaque Marker

    K Number: K201106 · Decision May 21, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    68
    Applicant Total
    6
    Review Days
    27

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    Basic Information

    Device Name
    IntraMarX 3D Radiopaque Marker
    K Number
    K201106
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1725
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Anx Robotica Corp
    Date Received
    April 24, 2020
    Decision Date
    May 21, 2020
    Product Code
    FFX
    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
    FFX System, Gastrointestinal Motility (Electrical)

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    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
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    Other Clearances by Anx Robotica Corp

    K Number Device Name
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    K230694 NaviCam Xpress Stomach System, NaviCam Xpress System
    K221608 NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether
    K203192 NaviCam Xpress Stomach System
    K191087 IntraMarX Radiopaque Markers