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

    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

    K Number: K221608 · Decision Nov 22, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    5
    Applicant Total
    6
    Review Days
    172

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    Basic Information

    Device Name
    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
    K Number
    K221608
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1310
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Anx Robotica Corp
    Date Received
    June 3, 2022
    Decision Date
    November 22, 2022
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QKZ), ordered by most recent decision date.

    NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NaviCam Xpress Stomach System, NaviCam Xpress System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NaviCam Xpress Stomach System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NaviCam Capsule Endoscope System with NaviCam Stomach Capsule

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Anx Robotica Corp

    K Number Device Name
    K241934 NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)
    K230694 NaviCam Xpress Stomach System, NaviCam Xpress System
    K203192 NaviCam Xpress Stomach System
    K201106 IntraMarX 3D Radiopaque Marker
    K191087 IntraMarX Radiopaque Markers