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510(k) Data Aggregation

    K Number
    K160969
    Device Name
    ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler
    Manufacturer
    Date Cleared
    2016-12-12

    (250 days)

    Product Code
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHINEMED LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ShineMed Reloadable Open Cutting Staplers (ROCS) have applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis. ShineMed Curved Intraluminal Cutting Staplers (CICS) have applications throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries, including bariatric surgery.
    Device Description
    Both ShineMed Reloadable Open Cutting Staplers and predicate DST Series™ GIA™ Staplers place two, double-staggered rows of titanium staples and simultaneously divide the tissues between the two double rows. The size of the staples is determined by the selection of the appropriate single use loading unit that is available in 60mm, 80mm, and 100mm lengths: - . 3.8mm staple size single use loading unit (blue cartridge) (60mm, 80mm, and 100mm lengths) - . 4.8mm staple size single use loading unit (green cartridge) (60mm, 80mm, and 100mm lengths) Both ShineMed Curved Intraluminal Cutting Staplers and predicate Autosuture™ Circular EEA™ Surgical Staplers place a circular, double staggered row of titanium staples and resect the excess tissue, creating a circular anastomosis. They are indicated for use in the creation of anastomoses in various surgical procedures in both open and laparoscopic surgeries. The stapler is offered in 25mm (white), 28mm (blue), and 31mm (green) diameters and with 4.8mm staple size.
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