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510(k) Data Aggregation

    K Number
    K131511
    Device Name
    DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORR
    Manufacturer
    CHANGZHOU SINOLINKS MEDICAL INNOVATION CO., LTD
    Date Cleared
    2013-07-05

    (38 days)

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

    CHANGZHOU SINOLINKS MEDICAL INNOVATION CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Circular Stapler has 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. The Disposable Linear Staplers and Reloads have application in the resection or transection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures. The Disposable Hemorrhoidal Staple has application for general surgical treatment of hemorrhoids. The Disposable Endoscopic Linear Cutter Staplers and Reloads have applications in general, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomoses. They may be used for transection of liver substance, hepatic vasculature and biliary structures. The Disposable Linear Cutter Staplers and Reloads have application in abdominal, gynecological, thoracic and pediatric surgery transection, resection, and the creation of anastomoses. The Disposable Curved Cutter Stapler is intended for transection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle), gynecologic, and thoracic surgical procedures.
    Device Description
    The proposed device, Disposable Circular Stapler is a sterilized and disposable surgical instrument intended to be used throughout the alimentary tract for the creation of end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries. It places a double staggered, circular row of titanium staples upon activation, which was actieved by squeezing the handles firmly as far as they could go. Immediately after formation of the staples, the excess tissue will be resected by the circular knife, and then a circular anastomosis is created. The staple is available in two specifications which are 4.8 mm and 5.2 mm to be used per different thickness of the tissue. The proposed device, Disposable Linear Staplers and Reloads is a sterilized and disposable surgical instrument intended to be used in the resection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures. It places a double staggered row of titanium staples and is available in 30 mm, 45 mm, 60mm and 94 mm staple line length for use in various applications. Four staple sizes (3.8mm ,4.5 mm and 4.8 mm) are available to accommodate various tissue thicknesses. Each stapler could be reloaded no more than 7 times for total 8 firings. The Disposable Linear Staplers and reloads have two configurations: (1) DLS serials are Disposable I he Disposable Linear Business and (2) DLR serials are reloads for Disposable Linear Staplers. Each of them has various specifications. The proposed device, Disposable Hemorrhoidal Stapier is a sterilized and disposable surgical The "proposed" Corner and surgical treatment of hemorrhoids. It is a set of instruments that place a double staggered, circular row of titanium staples. Immediately It is a set of insultions and photo a knowlar knife blade resects the excess of compressed mucosa. The aller the formation of supres, and them. Sets are commonly used in the procedures for prolapsed and Hemorrhoids. They are also used for sets are ochanced , and circular or semicircular stapling of anorectic tissue is required. The proposed device, Disposable Endoscopic Linear Cutter Staplers and Reloads is a sterilized and I ile proposed unstrument, which has applications in abdominal, gynecologic, pediatic and thoracic surgery for resection, and creation of anastomoses. They may be used for thoracter bargery 200 on of liver substance, hepatic vasculature and biliary structures. It places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The size of the staples is decided by selecting 3.5 mm, or 4.8 mm reload. The Endoscopic Linear Cutter can be adapted for all of the reload sizes available. The Disposable Endoscopic Linear Cutter Staplers and Reloads have two configurations: (1) DEC The Disposable Endoscopic Linear Cutter Staplers and Reloads, and (2) DER serials are sellas for Disposable Endoscopic Linear Cutter Staplers. Each of them has various specifications. Detail specifications are presented in Section 4.5 Model Description. The proposed device, Disposable Linear Cutter Staplers and Reloads is a sterilized and disposable surgical instrument, which has application in abdominal, gynecological, thoracic and pediatric surgery transection, resection, and the creation of anastomoses. It places two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The Disposable Linear Cutter Staplers and Reloads are available in 55 between the two 20 mm and 100 mm lengths. Reloads are available in four staple sizes to accommodate उन्द various tissue thicknesses: 3.8 mm, 4.0mm, 4.5mm and 4.8 mm. The Disposable Linear Cutter Staplers and Reloads has two configurations: (1) DLC serials is The Disposable Linear Cutter Staplers Disposable Linear Cutter Staplers with Reloads, and (2) DCR serials is Reloads for Disposable Linear Cutter Staplers. Each of them has various specifications. The proposed device, Disposable Curved Cutter Stapler is a sterilized and disposable surgical instrument, which is mainly suitable for low rectal resection and anastomosis of tissues where manual anastomosis is difficult. It places four staggered curved row of titanium staples on the tissue upon activation, and cut the tissue between staple lines.
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