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The AEON Endoscopic Powered Stapler has applications in general, abdominal, gynecologic, and pediatric surgery for resection, transection, and creation of anastomoses. The instrument may be used for transection of liver substance, hepatic vasculature, biliary structures, pancreas, kidney and spleen.

The AEON Endoscopic Powered Stapler system is an endoscopic linear cutter and reload system that simultaneously cut and staple tissue. The AEON Endoscopic Powered Stapler places two, triple-staggered rows of titanium staples while simultaneously transecting between the two triple-staggered rows of staples. The AEON Endoscopic Powered Stapler system is composed of an AEON Endoscopic Powered Stapler Handle and the AEON Endoscopic Stapler Reloads. Multiple staple handle lengths and multiple staple sizes are available to accommodate various tissue thicknesses. The AEON Endoscopic Powered Stapler uses software to control operation of the stapler and is AC powered. The device is sterile packaged (Ethylene Oxide) and single use. The AEON Endoscopic Powered Stapler Handle may be reloaded and fired up to 20 times in a single procedure.

AEONTM Laparoscopic Instruments is a family of instruments which includes forceps, scissors, and probes which are intended to be used in general laparoscopic surgical procedures requiring the use of monopolar electrosurgical cutting and/or coagulation.

The AEON Laparoscopic Instruments are sterile, disposable, single-use, individuallypackaged surgical instruments that are designed to cut, grasp, dissect, and coagulate selected tissue in laparoscopic surgery. The instruments are designed to be used with an electrosurgical generator (to be purchased separately). There are 10 different instrument tip configuration variants. The only difference between the 10 variants is the geometry of the tip scissors/graspers in three shaft working lengths 22cm, 33cm, and 45cm. Scissors and forceps have a handle with rotating wheel attached to an insulated shaft with different tips, which allows the shaft and tip to rotate. They include a male cautery connector when attached to standard monopolar cautery cables and generators. Probes/Electrodes have an insulated shaft with a thermally conductive metal tip electrode. The proximal end of the shaft is attached to a handle made of an injection molded, medical grade plastic. The proposed device is provided Ethylene Oxide (ETO) sterilized to achieve the Sterility Assurance Level (SAL) of 10^-6 and placed in a sterility maintenance package to ensure a shelf life of 3 years.

The AEON™ Endoscopic Stapler has applications in general, abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and creation of anastomoses.

The AEON™ Endoscopic Stapler places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from a central line. The size of the staples and staple line length are based on the selection of the Stapler Reload open staple height and staple line length. The AEON™ Endoscopic Stapler handle and reload are sterile, single use devices. The modification presented in this 510(k) is a change in the product Instructions for Use (IFU) labeling to add the following two (2) contraindications: - 1) "The AEON™ Endoscopic Stapler is contraindicated for use on the heart, central circulatory system, or central nervous system." - 2) "Do not use the AEON™ Endoscopic Stapler 2.0 mm staples on the aorta, any tissue that compresses to less than 0.75 mm in thickness, or any tissue that does not comfortably compress to 0.75 mm." This second contraindication is associated with the addition of an AEON Endoscopic Stapler reload staple height of 2.0mm and the compressed tissue thickness contraindication associated with this staple height.