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

    PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E

    K Number: K211684 · Decision Aug 27, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    46
    Applicant Total
    2
    Review Days
    87

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E
    K Number
    K211684
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Given Imaging Ltd. (Medtronic)
    Date Received
    June 1, 2021
    Decision Date
    August 27, 2021
    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

    Similar 510(k) Clearances

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

    MiroCam® Capsule Endoscope System

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

    CE Deliver (DLV)

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

    CapsoCam Plus (SV-3) Capsule Endoscopy System

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

    PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software

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

    NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether

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

    PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E

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

    Other Clearances by Given Imaging Ltd. (Medtronic)

    K Number Device Name
    K230991 PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E