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510(k) Data Aggregation

    K Number
    K161905
    Device Name
    Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge
    Date Cleared
    2016-11-17

    (129 days)

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

    CHANGZHOU XIN NENG YUAN MEDICAL STAPLER CO.,LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Disposable Circular Stapler has applications throughout the alimentary tract for the creation of end-to-end, end-to-side anastomoses in both open and laparoscopic surgeries. The Disposable Linear Stapler has application in the resection of tissue for abdominal. gynecological, pediatric and thoracic surgical procedures. The Disposable Endoscopic Linear Cutter Stapler and Cartridge has applications in general, gynecologic, pediatric and thoracic surgery for resection, transection of anastomoses. They may be used for transection and resection of liver substance and biliary structures. The Disposable Linear Cutter Stapler Cartridge has application in abdominal, gynecological, thoracic and pediatric surgery transection, resection and the creation of anastomoses. The Disposable Circular Stapler for Hemorrhoids has application for general treatment of hemorrhoids.
    Device Description
    The Disposable Linear Stapler places a double staggered row of titanium staples and is available in 30mm, 45mm, 60mm and 90mm staple line length for use in various applications. Two staple sizes (3.8mm and 4.5mm) are available to accommodate various tissue thicknesses. It may be reloaded and fired up to 2 times for a total 3 firing in a single procedure. Disposable Circular stapler 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. It is available in 20, 22, 24, 26, 29, 32mm six specifications. Two staple sizes (4.7mm and 5.6mm) are available to accommodate various tissue thicknesses. Disposable Endoscopic Linear Cutter Stapler and Cartridge places two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. It is available in 30mm, 45mm, 60mm staple line length for use in various applications. Three staple sizes (2.5mm, 3.5mm and 4.8mm) are available to accommodate various tissue thicknesses. It may be reloaded and fired up to 2 times for a total 3 firing in a single procedure. Disposable Linear Cutter Stapler Cartridge places a 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 4.5mm. It may be reloaded and fired up to 5 times for a total 6 firings in a single procedure. Disposable Circular Stapler for Hemorrhoids is 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 device is available in 34mm with 4.6mm staple.
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