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510(k) Data Aggregation

    K Number
    K093661
    Device Name
    COLONRING
    Date Cleared
    2011-02-10

    (442 days)

    Product Code
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    NITI SURGICAL SOLUTIONS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NiTi ColonRing™ device is intended for use throughout the alimentary tract for endto-end, end-to-side and side-to-side anastomoses, in both open and laparoscopic surgeries. Once wound strength is sufficient to maintain the anastomosis, the NiTi ColonRing™ is passed from the body.
    Device Description
    The ColonRing™ device is a sterile single use device. The ColonRing™ provides a simple method for the creation circular compression anastomosis of the alimentary tract. After a period of 7-10 days, a compression-induced necrosis of the tissue sides underneath the ring occurs and the whole device, together with the necrosed tissue that was compressed by the rings, detaches and is naturally expelled with the stool.
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