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The ENDOPATH® and PROXIMATE® Linear Cutters are intended for transection, resection, and/or creation of anastomoses.

K821994: The Disposable Linear Stapler has application in abdominal, thoracic, and pediatric surgery for resection and transection of internal tissues. The total thickness of the tissues being connected must be within the range of 1.0 to 3.0 mm.

K843034: The PLC50 has application in abdominal, pediatric and thoracic surgery for resection, transection and creation of anastomoses.

K892927: The LCT75 has application in gastrointestinal and thoracic surgery for resection, transection and creation of anastomoses. Cartridges for the standard (PLC75) and Thick Tissue (LCT75) are interchangeable within these instruments.

K915099: The ENDOPATH Endoscopic Linear Cutter with Safety Lock-out has applications multiple open or endoscopic procedures for the transection, resection and creation of anastomosis.

K930934: The ENDOPATH Endoscopic Reloadable Linear Cutter with Safety Lock-Out has application in gastrointestinal and thoracic surgery for transection, resection and creation of anastomoses.

K935064: The ENDOPATH Endoscopic Linear Cutter with Safety Lock-Out has application in multiple open or endoscopic procedures for the transection, resection, and creation of anastomoses.

K945202: The ENDOPATH Endoscopic Reloadable Linear Cutter with Safety Lock-Out has multiple open or endoscopic procedures for transection. resection and/or creation of anastomoses.

K951546: [Verbiage for all of the various indication statements remain the same, plus] ... and can be used with staple line or tissue buttressing materials, such as bovine pericardium.

K961264: The ENDOPATH® EZ-RF Linear Cutter and Coagulation device has applications in open and minimally invasive surgical procedures for coagulation, transection, and resection of tissue. The bipolar feature is to be used only with the ERBE ERBOTOM ICC 350 or the Valleylab Force 2 electrosurgical generators.

K961390: The ENDOPATH ETS Endoscopic Linear Cutter and ETS-FLEX Endoscopic Articulating Linear Cutter have application in general, urologic, gynecologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.

K970720: The ENDOPATH EZ45 Endoscopic Linear Cutter has application in multiple open or other minimally invasive surgical procedures for transection, resection, and/or creation of anastomoses and can be used with staple line or tissue buttressing materials, such as bovine pericardium. and

The ENDOPATH EZ45 No Knife Endoscopic Linear Stapler has application in multiple open or other minimally invasive surgical procedures for transection and resection, and can be used with staple line or buttressing materials, such as bovine pericardium.

All device functions, scientific concepts, significant physical and performance characteristics (i.e. device design, materials, physical properties, etc.) have not changed from the above-mentioned 510(k)s.

This document is a 510(k) Summary of Safety and Effectiveness for the ENDOPATH® and PROXIMATE® Linear Cutters. It is a submission to the FDA seeking clearance for these devices.

The document does not describe acceptance criteria, nor does it present a study proving the device meets specific performance criteria. Instead, it states that the device's functions, scientific concepts, physical and performance characteristics have not changed from previously cleared 510(k) devices. This type of submission relies on demonstrating substantial equivalence to predicate devices, rather than presenting new performance studies against specific acceptance criteria.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them because this document does not contain that type of information. It explicitly states:

• "All device functions, scientific concepts, significant physical and performance characteristics (i.e. device design, materials, physical properties, etc.) have not changed from the above-mentioned 510(k)s."
• "The ENDOPATH® and PROXIMATE® Linear Cutters' performances have not changed from the above-mentioned 510(k)s."

This suggests that the performance metrics were established and validated for the predicate devices, and because the current device is substantially equivalent and unchanged in these aspects, no new performance studies are presented in this 510(k) submission.

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