BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E

    K Number: K230991 · Decision Jun 30, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    46
    Applicant Total
    2
    Review Days
    85

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    Basic Information

    Device Name
    PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E
    K Number
    K230991
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Given Imaging Ltd. (Medtronic)
    Date Received
    April 6, 2023
    Decision Date
    June 30, 2023
    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 Given Imaging Ltd. (Medtronic)

    K Number Device Name
    K211684 PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E