(56 days)
The ENDOPATH ETS Endoscopic Linear Cutter and ETS-Flex Endoscopic Articulating Linear Cutter has application in general, gynecologic, and thoracic surgery for transcction, resection, and/or creation of anastomoses. The instruments may also be used for transcotion and resection of liver parcnchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
The ENDOPATH ETS45 Endoscopic Linear Cutters, the ETS-Flex45 Endoscopic Articulating Linear Cutters, and the ETS Compact-Flex45 Articulating Linear Cutters are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials. The instruments may also be used for transcetion and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
The ENDOPATII ETS-Flex45 No-Knife Articulating Linear Staplers and the ETS Compact-Flex45 No-Knife Articulating Linear Staplers are intended for transection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple linc or tissue buttressing materials. The instruments may also be used for transection and resection of liver parcnchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
The ENDOPATH ETS Flex60 Endoscopic Articulating Long Lincar Cutter is intended for transection, rescction, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general, gynecologic, thoracic, and pediatric surgical procedures. It can be used with staple line or tissue buttressing materials. The instrument may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and splecn.
The ENDOPATH E745 Endoscopic Linear Cutter has application in multiple open and other minimally invasive surgical procedures for transection, and/or creation of anastomoses. They can be used with staple line or tissue buttressing materials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
The ENDOPATH EZ45 No-Knife Endoscopic Linear Stapler has application in multiple open or other minimally invasive surgical procedures for transection. They can be used with staple line or tissue buttressing matcrials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
The ENDOPATH EZ45 Thoracic Endoscopic Linear Cutter has application in thoracic surgery or other minimally invasive surgical procedures for transection, and/or creation of anastomoses. They can be used with staple line buttressing matcrials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
The Echelon60 Endoscopic Linear Cutter is intended for transection, and/or creation, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials. The instrument may also be used for transection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device: "ENDOPATH and Echelon Linear Cutter and Staplers." It is a regulatory approval document and does not contain acceptance criteria or a study proving the device meets acceptance criteria.
The letter states that the FDA has reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. Substantial equivalence means that the new device is as safe and effective as a legally marketed device (the predicate device) and does not need to go through the more rigorous Premarket Approval (PMA) process.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone studies cannot be extracted from the provided text. This information would typically be found in the 510(k) submission itself, which is a much more detailed document than the clearance letter.
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.