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The Reprocessed Reloadable AutoSuture GIA staplers are intended to be used in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and anastomosis. In addition the AutoSuture ENDO GIA Staplers may be used for transection of liver lissue, hepatic vasculature and biliary structures.

SterilMed's reprocessed AutoSuture GIA Endoscopic Stapler places two triple staggered rows of titanium staples and the blade, contained in the reload, simultaneously divides the tissue between the two rows. These devices allow for a maximum of 8 reloads in a single surgical procedure. The OEM has specified that the subject staplers may be fired up to 25 times in a single surgical procedure. SterilMed has lowered the number of firings allowed to 8 based upon clinical input, the procedures these devices are used for and the maximum allowable firings for similar devices of other manufactures. Note: Only the stapler is the subject of this submission, the implantable staple and the staple cartridge are not reprocessed and therefore are not included.

The ETS 45, ETS-Flex45, and Compact-Flex 45 reprocessed, reloadable Endoscopic Linear Cutters are intended for transection, resection and/or anastomosis. These instruments have applications in open and minimally invasive general, gynecologic, urologic (including radical prostatectomy), thoracic and pediatric surgery. The ETS Flex 45, ETS 45 and ETS Compact Flex 45 device can be used with staple line or tissue buttressing materials such as bovine pericardium. The ETS and ETS-Flex (articulating) reprocessed, reloadable Endoscopic Linear Cutters (35mm) have applications in general, gynecologic, urologic, and thoracic surgery for transection, and/or creation of anastomoses.

SterilMed's reprocessed Ethicon ETS Linear Cutter is a sterile, single patient use device. It delivers two double-staggered or two triple-staggered rows of staples while simultaneously dividing the tissue between the rows of staples. An articulation lever on the ETS-Flex Linear Cutter enables bilateral movement of the instrument jaws. These devices are reloadable linear cutters that allow for a maximum of 8 firings in a single surgical procedure. Note: Only the linear cutter is the subject of this submission, the implantable staple and the staple cartridge are not reprocessed and therefore are not included.

Reloadable Cutters The ClearMedical Reprocessed Reloadable Cutters are intended for transection, resection, and creation of anastomoses in gastrointestinal, gynecologic, thoracic, and pediatric surgery. Reloadable Staplers The ClearMedical Reprocessed Reloadable Staplers are intended for the resection of tissues in the alimentary tract and in thoracic surgery.

The Reprocessed Reloadable Cutters deliver two double-staggered rows of titanium staples while dividing the tissue between the rows. The reloadable cutters may be reloaded during a single procedure, up to a maximum number of firings per instrument as stated in the product insert. The Reprocessed Reloadable Staplers deliver two double-staggered rows of titanium staples to approximate internal tissues. The reloadable cutters may be reloaded during a single procedure, up to a maximum number of firings per instrument as stated in the product insert.