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ECHELON ENDOPATH Staple Line Reinforcement is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. ECHELON ENDOPATH Staple Line Reinforcement can be used for reinforcement of staple lines during lung resection and bariatric surgical procedures. The device can also be used for reinforcement of staple lines during gastric, small bowel, and colorectal procedures.

Echelon Endopath Staple Line Reinforcement is a staple line reinforcement, also known as a buttress, for use in the surgical environment for the purpose of reinforcing a staple line. The Subject Device of this 510(k) is the same as the Predicate Device with a modification to the labeling to include the addition of the Intuitive Surgical SureForm™ 60 mm Blue, Green and Black Reloads and SureForm™ 60 mm Stapler 510(k) Cleared K173721 as compatible devices. The Predicate Device is compatible with the Echelon Flex™ 60 mm Powered Plus Articulating Endoscopic Linear Cutters with Echelon Endopath 60 mm Endoscopic Linear Cutter Reloads with Gripping Surface Technology, (510k cleared K202665, K183435). There are no design or manufacturing changes associated with this submission. The Subject Device is to be used with surgical stapling devices. Surgical stapling devices place staggered rows of staples with a reinforcement material, and simultaneously divide the tissue and the reinforcement material between the stapled rows. The Subject Device is an absorbable staple line reinforcement material which is secured to both the stapler anvil and reload with a synthetic attachment material. The product consists of an applicator which includes the implantable device, one for each of the upper and lower stapler jaws. The implantable material consists of 3 materials: the Vicryl material, the Polydioxanone film and the attachment adhesive material. Echelon Endopath Staple Line Reinforcement is an implanted material which works as an adjunct to surgical staples after transection, to provide support to soft tissue during the healing process. There are no modifications to the predicate device; and the materials of the Subject Device and Predicate Device are the same. Each unit is packaged sterile in separate pouch.

The Ethicon™ Circular Staplers have application throughout the alimentary tract for end, end-to-soside anastomoses.

The Ethicon™ Circular Staplers are sterile, single use devices that simultaneously staple and cut tissue to create an anastomosis. The devices deliver 2 concentric rows of staples on the outside of the cut line. The Ethicon™ Circular Staplers are available in two device configurations: CDH and ECS and two shaft lengths; a standard 26 cm shaft and an XL 37 cm shaft. Each configuration is available in 4 endeffector sizes: 21 mm, 29 mm, 33 mm. These configurations function in the same manner - to compress tissue and to produce the same closed staple on tissue. Each device has a detachable anvil that allows a surgeon to place the anvil in the desired location.

ECHELON ENDOPATH Staple Line Reinforcement is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. ECHELON ENDOPATH Staple Line Reinforcement can be used for reinforcement of staple lines during lung resection and bariatric surgical procedures. The device can also be used for reinforcement of staple lines during gastric, small bowel and colorectal procedures.

Echelon Endopath Staple Line Reinforcement is a staple line reinforcement, also known as a buttress, for use in the surgical environment for the purpose of reinforcing a staple line. The Subject Device is to be used Echelon Endopath GST 60 mm reloads in conjunction with the Echelon family of 60 mm endoscopic linear cutters. The Echelon 60 mm Stapler in conjunction with the Echelon Endopath GST60 mm reload places staggered rows of titanium staples with a reinforcement material, and simultaneously divide the tissue and the reinforcement material between the stapled rows. The Subject Device is an absorbable staple line reinforcement material which is secured to the stapler anvil and reload with a synthetic attachment material. The Subject Device contains an applicator and the implantable device which consists of 3 materials: the Vicryl material, the Polydioxanone film and the attachment material. Echelon Endopath Staple Line Reinforcement is an implanted material which works as an adjunct to surgical staples after transection, to provide support to soft tissue during the healing process. Echelon Endopath Staple Line Reinforcement is composed of undyed multifilament fibers identical to those used in Vicryl surgical sutures. The polyglactin 910 implant is knitted by a process which interlocks each fiber juncture to prevent unraveling. The implanted material consists of a Vicryl layer laminated with a PDO film on each side, and a Buttress Attachment Material which is a synthetic material applied to the top outer surface of each implant. The staple line reinforcement is used as a buttress to provide support during the healing process. Both Subject and Predicate materials are hydrolyzed by body fluids and absorbed after serving the intended function. The subject Device absorption is essentially complete at 120 days. The primary difference between the Subject and Predicate Devices is the feature for loading and delivery of the device to the implantation site. A thin layer of bioabsorbable adhesive is coated onto one surface of the implantable device and is composed of a synthetic polymer/poloxamer blend to attach the Subject Device to the stapler. Whereas the Predicate Device utilized a sleeve construction and suture pullcord to secure the reinforcement material on the stapler.