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The EndoGastric Solutions, StomaphyX System with SerosaFuse Fastener is intended for transoral tissue approximation, ligation and full-thickness plication in the G.I. tract.

The EndoGastric Solutions StomaphyX Delivery System and Implantable Fasteners consist of an ergonomic, flexible fastener delivery device and sterile polypropylene fastener implants delivered through a fastener cartridge. The unit is provided sterile and is a single use device. The polypropylene fasteners are proprietary and function only with the StomaphyX device, The device uses vacuum to invaginate tissue through a port into a chamber and fastens it using Hshaped polypropylene fasteners. The fastener delivery subsystem is comprised of 3 elements: stylet, pusher, and internal lumens. The three elements run the length of the device, inside the outer shaft. The pusher is a hollow tube that rides over the length of the stylet provides a "pilot" hole for the fastener to pass through the tissue and both ride inside the lumen. The stylet is a wire three-faceted, sharpened tip at the distal end to pierce tissue. A fastener is loaded for deployment by depressing the lever on the removable, fastener cartridge located at the proximal end of the device. This action automatically snaps the fastener onto the stylet. When the pusher tube is pushed by the operator, the stylet carnes the fastener down the lumen which runs from the proximal handle assembly to the distal tissue port where it will eventually be deployed into the tissue.

This 510(k) summary does not contain information on device acceptance criteria or a study proving the device meets those criteria. The provided text is a summary of a 510(k) submission for a medical device (StomaphyX Delivery Device and Fasteners) seeking substantial equivalence to predicate devices. It describes the device, its intended use, and compares it to existing predicate devices. It also includes the FDA's clearance letter.

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