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510(k) Data Aggregation

    K Number
    K211811
    Device Name
    Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers
    Date Cleared
    2022-03-03

    (265 days)

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

    Wuxi Beien Surgery Device Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Disposable circular staplers have application throughout the alimentary tract for end to side, and side to side anastomoses. The Disposable Endoscopic Staplers and Reload Unit have applications in general, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomoses. The Disposable Hemorrhoidal Cutter Staplers have application for general treatment of hemorrhoids. Disposable Linear Cutter Staplers have application in abdominal, gynecological, thoracic and pediatric surgery transection, resection, and the creation of anastomoses.
    Device Description
    Disposable circular staplers place 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 23mm, 32mm and 34mm four specifications. The staple height is 4.8mm. Disposable Endoscopic Staplers and Reload Unit place two, triple-staggered rows of progressive 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 2.5mm, 4.0mm, 4.8mm four staple sizes and 3.0~4.0, 4.0~5.0 two progressive staple sizes to accommodate various tissue thicknesses. The device may be reloaded and fired up to 10 times in a single procedure. Disposable Hemorrhoidal Cutter Staplers are a set of instruments 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 32mm two specifications. The staple size is 4.0mm. It cannot be reloaded. Disposable Linear Cutter Staplers place 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 5 times in a single procedure.
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