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510(k) Data Aggregation

    K Number
    K162947
    Device Name
    Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit; Linear Cutting Stapler and Single Use Loading Unit; Disposal Hemorrhoidal Circular Stapler
    Date Cleared
    2017-03-03

    (133 days)

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

    CHONGQING QMI SURGICAL CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Disposable End-to-end Anastomosis Circular Stapler has applications throughout the alimentary tract for the creation of end-to end, side-to-side and end-to-side anastomoses in both open and laparoscopic surgeries, including bariatric surgery. The Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and for transection and resection and resection of pancreas. The Linear Cutting Stapler and Single Use Loading Unit has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection and creation of anastomosis. The stapler may be used for occlusion of the left atrial appendage in open procedures. They may be used for transection of pancreas. The Disposable Hemorrhoidal Circular Stapler has application throughout the anal to perform surgical treatment of hemorrhoidal disease.
    Device Description
    Disposable End-to-end Anastomosis Circular Stapler places a double staggered, circular row of titanium staples upon activation, which was achieved by squeezing the handles firmly as far as they could go. Immediately after formation of the staples, the excess tissue will be resect by the circular knife, and then a circular anastomosis is created. The stapler are available in 25mm and 31mm three specifications. The staple size is 4.8 mm. Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit places two, triple-staggered rows of progressive or equal titanium staples and simultaneously divides the tissue from central line. The devices are available in 30mm, 45mm and 60mm three lengths. Reloads are available in staple sizes 2mm-3mm, 3mm-4mm, 2.5mm, 4.0mm. 4.8mm to accommodate various tissue thicknesses. The device may be reloaded and fired up to 25 times in a single procedure. Linear Cutting Stapler and Single Use Loading Unit places two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The devices are available in 60mm, 80mm and 100mm lengths. Reloads are available in two staple sizes to accommodate various tissue thicknesses: 3.8mm and 4.8mm. It may be reloaded and fired up to 7 times for a total 8 firings in a single procedure. Disposable Hemorrhoidal Circular Stapler is a set of instrument that place a double staggered, circular row of titanium staples. Immediately after the formation of staples, the circular knife blade resects the excess of compressed mucosa. The stapler is available in 33mm one specification. The staple size is 4.5mm. It cannot be reloaded.
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