(27 days)
The ENDOPATH Endocutter 60 Endoscopic Linear Cutter is intended for transection, resection, 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.
ENDOPATH Endocutter 60 Endoscopic Linear Cutter models are sterile, single patient use instruments that deliver staples while simultaneously dividing tissue between rows. These instruments may be used in either open or endoscopic procedures. The devices will be available in three shaft lengths: standard, compact and long, and will be furnished without a cartridge. Cartridges for the Endocutter 60 devices will be available in sizes that correspond to the thickness of tissue that is to be transected or resected: white (vascular/thin), blue (standard), gold (thick, less dense) and green (thick).
The provided text does not contain specific acceptance criteria or details of a study that proves the device meets those criteria. It describes the device, its intended use, and its technological characteristics. It also states that "Bench testing and preclinical laboratory evaluations were performed to demonstrate that the device will perform as intended," but it does not provide any results, specific criteria, or details about these tests.
Therefore, I cannot provide the requested information in the structured table and numbered points.
The document is a 510(k) summary for a medical device (ENDOPATH Endocutter 60 Endoscopic Linear Cutter), which typically provides an overview of the device and its equivalence to a predicate device, rather than detailed study results or performance data. Such detailed information is usually found in the full 510(k) submission, which is not provided here.
§ 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.