BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    NaviCam Small Bowel Capsule Endoscopy System

    K Number: K221590 · Decision Dec 2, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    46
    Applicant Total
    2
    Review Days
    183

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    Basic Information

    Device Name
    NaviCam Small Bowel Capsule Endoscopy System
    K Number
    K221590
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ankon Technologies Co., Ltd.
    Date Received
    June 2, 2022
    Decision Date
    December 2, 2022
    Product Code
    NEZ
    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
    NEZ System, Imaging, Gastrointestinal, Wireless, Capsule

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    Other Clearances by Ankon Technologies Co., Ltd.

    K Number Device Name
    DEN230027 NaviCam ProScan