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510(k) Data Aggregation

    K Number
    K182217
    Device Name
    Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use
    Date Cleared
    2019-04-16

    (244 days)

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

    Ezisurg (Suzhou) Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Linear Cutter Staplers and Loading Units for Single Use have application in gastrointestinal for transection, resection, and/or creation of anastomoses. The Circular Staplers for Single Use has applications throughout the alimentary for end-to-end, end-to-side and side-to-side anastomoses.
    Device Description
    The Linear Cutter Staplers and Loading Units for Single Use place two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The device is available in 60mm, 80mm and 100mm length with reload in 2.5mm and 4.5mm staple size to accommodate various tissue thicknesses. The device may be reloaded and fired up to 8 times in a single procedure. The Circular Staplers for Single Use 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 is available in 33mm, 29mm, 25mm and 21mm five specifications. Two staple sizes (3.5mm and 4.8mm) are available to accommodate various tissue thicknesses.
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    K Number
    K181620
    Device Name
    Endoscopic Linear Cutting Staplers and Loading Units for Single Use
    Date Cleared
    2018-09-18

    (90 days)

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

    Ezisurg (Suzhou) Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended for transection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures.
    Device Description
    The proposed device places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The device is available in 70mm, 160mm three lengths. Reloads of Endoscopic Linear Cutting Staplers and Loading Units for Single Use are available in in five staple sizes to accommodate various tissue thickness: 2.5mm, 3.5mm, 4.1mm and 4.8mm. The device may be reloaded and fired up to 25 times for 1 firing in a single procedure.
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