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

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

    K Number: K231960 · Decision Oct 3, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    5
    Applicant Total
    3
    Review Days
    92

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    Basic Information

    Device Name
    NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether
    K Number
    K231960
    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 Corporation
    Date Received
    July 3, 2023
    Decision Date
    October 3, 2023
    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 System, NaviCam Xpress System

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    FDA Class 2 ·Gastroenterology, Urology

    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

    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 Corporation

    K Number Device Name
    K250493 MotiliCap GI Monitoring System
    K233229 NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether