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The EndoGastric Solutions EsophyX Z+ Device with SerosaFuse Fasteners and Accessories is indicated for use in transoral tissue approximation, full thickness plication in the GI tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. It is also indicated to narrow the junction and reduce hiatal hernia ≤ 2cm in size in patients with symptomatic chronic gastroesophageal reflux disease. Patients with hiatal hernias larger than 2cm may be included, when a laparoscopic hiatal hernia repair reduces the hernia to 2cm or less.

The EsophyX Z+ Device with SerosaFuse Fasteners and Accessories is a prescription use only, disposable, single-use, sterile system consisting of an all-mechanical, flexible fastener delivery device with user controls outside the patient's body. The transoral device and tissue fasteners are provided sterile by ethylene oxide (EO). The delivery device is limited contact and materials include acrylic/polycarbonate plastics, machined aluminum, stainless steel, nitinol wire, UV cured adhesives, pellethane and nylon. The permanent contact, implantable SerosaFuse tissue fasteners are constructed of injection molded polypropylene and are of a strength equivalent to 3-0 suture. The SerosaFuse Implantable Fastener Cartridge is dual-lever containing 20 fasteners in each lever, and is designed to be removable. Each fastener consists of a leading leg, interconnecting web and trailing leg. The fastener's unique design allows it to be loaded onto a stylet, passed into and down a small delivery lumen of the device and subsequently delivered through apposed tissue surfaces in the GI tract. When deployed in tissue, the fastener serves as a suture-like implantable. The system is used in an operating room environment, using the Transoral Incisionless Fundoplication (TIF) procedure. The EsophyX Z+ device deploys the SerosaFuse fastener during an endoscopic procedure. A separate commercial endoscope operating independently down the center of the device's flexible shaft lumen provides visualization of the procedure from device insertion through extraction. The EsophyX Z+ device is capable of transoral tissue approximation, ligation, and full thickness plication in the GI tract. The process essentially mimics the standard surgical technique of grasping tissue and apposing/approximating the tissue, piercing, and suturing the tissue fold. Each of these steps is controlled at the device proximal end, though plication, ligation and gastroesophageal valve formation is accomplished at the distal end of the device.

The EndoGastric Solutions EsophyX, HD Device with SerosaFuse Fasteners and Accessories is indicated for use in transoral tissue approximation, full thickness plication in the Gl tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. It is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia ≤ 2cm in size in patients with symptomatic chronic gastroesophageal reflux disease. Patients with hiatal hernias larger than 2cm may be included, when a laparoscopic hiatal hernia repair reduces the hernia to 2cm or less, The EndoGastric Solutions EsophyX Z Device with SerosaFuse Fasteners and Accessories is indicated for use in transoral tissue approximation, full thickness plication in the GI tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. It is also indicated to narrow the gastroesophageal iunction and reduce hiatal hernia ≤ 2cm in size in patients with symptomatic chronic qastroesophaqeal reflux disease. Patients with hiatal hernias larger than 2cm may be included, when a laparoscopic hiatal hernia repair reduces the hernia to 2cm or less.

The EndoGastric Solutions EsophyX Device models (EsophyX2 HD and EsophyX Z, K171307) with SerosaFuse Fasteners and Accessories are a prescription use only, disposable, single use systems consisting of an all mechanical, flexible fastener delivery device with user controls outside the patient's body. The devices are used in an operating room environment, using the Transoral Incisionless Fundoplication (TIF) procedure. The device is limited contact and materials include acrylic/polycarbonate plastics, machined aluminum, stainless steel, nitinol wire, UV cured adhesives, pellethane and nylon. The permanent contact, implantable tissue fasteners are constructed of injection molded polypropylene. These transoral devices and tissue fasteners are provided sterile (EO). A separate, commercial endoscope operating independently down the center of the devices' flexible shaft lumen provides visualization of the procedure at all times, from device insertion through extraction. Two fasteners are loaded from a replaceable fastener cartridge containing ten fasteners for each channel. The loaded fasteners are pushed from the proximal device end, to the distal end down two separate channels via lumens in a flexible shaft where they are then in position ready for deployment into tissue. The operator, controlling the distal end of the devices through the mechanical controls at the proximal end of the devices, captures and positions a fold of tissue at the gastroesophageal junction. The fastener controls deploy both fasteners simultaneously in the EsophyX Z model, or individually in the EsophyX2 HD model, at the captured tissue position. This creates a permanent surgical partial fundoplication. Additional fasteners are used as needed to complete the valve restoration.

EsophyX2 HD Device with SerosaFuse Fasteners and Accessories: The EndoGastric Solutions EsophyX2 HD Device with SerosaFuse Fasteners and Accessories is indicated for use in transoral tissue approximation, full thickness plication and ligation in the GI tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. It is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia < 2cm in size in patients with symptomatic chronic gastroesophageal reflux disease. Patients with hiatal hernias larger than 2cm may be included, when a laparoscopic hiatal hernia repair reduces the hernia to 2cm or less. EsophyX Z Device with SerosaFuse Fasteners and Accessories: The EndoGastric Solutions EsophyX Z Device with SerosaFuse Fasteners and Accessories is indicated for use in transoral tissue approximation, full thickness plication and ligation in the GI tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. It is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia ≤ 2cm in size in patients with symptomatic chronic gastroesophageal reflux disease. Patients with hiatal hernias larger than 2cm may be included, when a laparoscopic hiatal hernia repair reduces the hernia to 2cm or less.

The subject EsophyX devices are unchanged from the currently cleared devices. The principles of operation for the devices are the same and also remain unchanged from the prior clearances. The indications for use for both models are identical. The EndoGastric Solutions EsophyX Device models (EsophyX2 HD and EsophyX Z, K142113 and K160960, respectively) with SerosaFuse Fasteners and Accessories are a prescription use only, disposable, single use system consisting of an all mechanical, flexible fastener delivery device with user controls outside the patient's body. The devices are used in an operating room environment, using the Transoral Incisionless Fundoplication (TIF) procedure. The device is classified as a surface device, mucosal membrane contacting with limited duration. The fastener classification is an implant, with permanent tissue/bone contact. Materials include acrylic/polycarbonate plastics, machined aluminum, stainless steel, nitinol wire, UV cured adhesives, pellethane and nylon. The implantable tissue fasteners are constructed of injection molded polypropylene. These transoral devices and tissue fasteners are provided sterile (EO). A separate, commercial endoscope operating independently down the center of the devices' flexible shaft lumen provides visualization of the procedure at all times, from device insertion through extraction. Two fasteners are loaded from a replaceable fastener cartridge containing ten fasteners for each channel. The loaded fasteners are pushed from the proximal device end. to the distal end down two separate channels via lumens in a flexible shaft where they are then in position ready for deployment into tissue. The operator, controlling the distal end of the devices through the mechanical controls at the proximal end of the devices, captures and positions a fold of tissue at the gastroesophageal junction. The fastener controls deploy both fasteners simultaneously in the EsophyX Z model, or individually in the EsophyXo HD model, at the captured tissue position. This creates a permanent surgical partial fundoplication. Additional fasteners are used as needed to complete the valve restoration.

The EndoGastric Solutions EsophyX Z Device with SerosaFuse is indicated for use in transoral tissue approximation, full thickness plication and ligation in the GI tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. It is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia ≤ 2cm in size in patients with symptomatic chronic gastroesophageal reflux disease.

The EndoGastric Solutions EsophyX Z Device with SerosaFuse Fasteners and Accessories is a prescription use only, disposable, single use system consisting of an all mechanical, flexible fastener delivery device with user controls outside the patient's body. The transoral device and tissue fasteners are provided sterile (EO). A separate, commercial endoscope operating independently down the center of the device's flexible shaft lumen provides visualization of the procedure from device insertion through extraction. Two polypropylene fasteners are loaded from a replaceable fastener cartridge containing ten fasteners for each channel. The loaded fasteners are pushed simultaneously from the proximal device end, to the distal end down two separate channels via lumens in a flexible shaft where they are then in position for deployment into the tissue. The operator, controlling the distal end of the device through the mechanical controls captures and positions a fold of tissue at the gastroesophageal junction. The delivery trigger mechanism deploys both fasteners simultaneously at the captured tissue position, creating a permanent surgical fundoplication. Additional fasteners are used as needed to complete the valve restoration.

The EndoGastric Solutions EsophyX Z Fastener Delivery Device with SerosaFuse Fasteners and Accessories is indicated for use in transoral tissue approximation, full thickness plication and ligation in the GI tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. It is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia < 2cm in size in patients with symptomatic chronic gastroesophageal reflux disease.

The EndoGastric Solutions EsophyX Z Fastener Delivery Device with SerosaFuse Fasteners and Accessories is a disposable, single use system consisting of an all mechanical, flexible fastener delivery device with user controls outside the patient's body. The transoral device and tissue fasteners are provided sterile (EO). A separate, commercial endoscope operating independently down the center of the device's flexible shaft lumen provides visualization of the procedure from device insertion through extraction. Two polypropylene fasteners are loaded from a replaceable fastener cartridge containing ten fasteners for each channel. The loaded fasteners are pushed simultaneously from the proximal device end, to the distal end down two separate channels via lumens in a flexible shaft where they are then in position for deployment into the tissue. The operator, controlling the distal end of the device through the mechanical controls captures and positions a fold of tissue at the gastroesophageal junction. The delivery trigger mechanism deploys both fasteners simultaneously at the captured tissue position, creating a permanent surgical fundoplication. Additional fasteners are used as needed to complete the valve restoration.

The EndoGastric Solutions EsophyX® 2 HD Device with SerosaFuse is indicated for use in transoral tissue approximation, full thickness plication in the GI tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. It is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia < 2cm in size in patients with symptomatic chronic gastroesophageal reflux disease.

The EndoGastric Solutions EsophyX® 2 HD Device with SerosaFuse Fasteners and Accessories consists of an all mechanical, flexible fastener delivery device with user controls outside the patient's body and sterile polypropylene fasteners delivered transorally through a flexible shaft into the GI tract via a common delivery mechanism comprised of three elements: a stylet, a pusher rod, and a delivery tube. All three fastener delivery elements run the length of the delivery device. The stylet runs down the inside of the lumen of the delivery tube and the pusher rod rides over the length of the stylet. The stylet is designed to pierce and hold the desired tissue plication in place and guide the fastener into position. There are two separate tubes or channels in the device, referred to as the posterior and anterior channels. A fastener is loaded mechanically onto the stylet via a replaceable fastener cartridge containing ten fasteners for each channel. To load, the fastener cartridge lever is depressed, which snaps a fastener onto the stylet. The fastener is then pushed down the stylet from the proximal handle assembly to the distal tissue port via the pusher rod where it is then ready to be deployed into the tissue. When the desired tissue approximation/ plication is achieved, the pusher rod is used to push the fastener into the tissue, quided by the stylet which precedes it into the tissue. The leading leq of the fastener slides along the stylet into the tissue. Slight additional pressure advances the pusher causing the leading leg of the fastener to disengage from the stylet and the fastener then seats across the desired tissue plication. A new fastener is loaded proximally in the device at the loading port, after retracting the pusher rod. The loading and fastening procedure can be repeated. The device is provided sterile and is a single use device.

The EndoGastric Solutions EsophyX2 Device with SerosaFuse Fastener and Accessories is indicated for use in transoral tissue approximation, full thickness plication in the GI tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. It is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia < 2cm in patients with symptomatic chronic gastroesophageal reflux disease.

The EndoGastric Solutions, EsophyX2 device with SerosaFuse Fasteners consist of an all mechanical, flexible fastener delivery device with user controls outside the patient's body and sterile polypropylene fasters delivered transorally through a flexible shaft into the Oldy and sterile delivery mechanism comprised of three elements a flexible shaft into the OI tra delivery mechanism comprised of three elements: a style, a pusher rod, and a delivery tube. All three fastener delivery elements run the letinents. I sylet, a pusher rod, and a delivery tube. All three the luments run the delivery tube and the purpos nod ide. The Stylet runs the lumen of the delivery tube and the pusher rod rides over the length of the stylet. The stylet is designed to pierce and hold the pusher fou nace over the length of the stylet is designed to pierce and hold the desired tissue plication in place and guide the fastener into. There are two separate tubes or channels in the device, referred to as the posterior and anterior channels. A fastener is loaded automatically onto the stylet via a replaceable fastener cartridge containing ten fasteners for each channel. To load, the fastener cartridge lever is depressed, which snaps a fastener onto the stylet. The fastener is then pushed down the proximal handle assembly to the distal tissue port via the pusher rod where it is then ready to be deployed into the tissue. When the desired tissue approximation/ plication is achieved, the pusher rod is used to push the fastener into the tissue, guided by the stylet which precedes it into the tissue. The leading leg of the fastener slides along the stylet into the tissue. Slight additional pressure advances the pusher causing leg of the fastener to disengage from the stylet and the fastener then seats across the desired tissue, plication. A new fastener is loaded proximally in the device at the loading port, after retracting the pusher rod. The loading and fastening procedure can be repeated. The unit is provided sterile and is a single use device.

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.

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

The EndoGastric Solutions StomaphyX™ Delivery Device and Implantable Fasteners consist of an ergonomic, flexible fastener delivery device and sterile polypropylene fastener implants. 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 fasten it using H shaped polypropylene fastener delivery subsystem is comprised of 3 elements: stylet, pusher, and internal lumens. They run the length of the device, the pusher being a hollow tube that rides over the length of the stylet, both riding in the lumen. The stylet is sharp at the distal tip to pierce tissue. The fastener is loaded by snapping it onto the stylet in the loading port of the handle. When pushed by the operator, the stylet carries 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.

The EndoGastric Solutions (EGS) EsophyX™ System with SerosaFuse™ Fastener is indicated for use in endoluminal, transoral tissue approximation, full thickness plication and ligation in the GI tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. It is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia ≤ 2cm in size in patients with symptomatic chronic gastroesophageal reflux disease.

The EndoGastric Solutions SerosaFuse™ implantable fasteners, and associated EsophyX delivery device and accessories consist of sterile polypropylene fastener implants and an ergonomic, flexible fastener delivery device. The fasteners and delivery devices are provided sterile and are for single use. The polypropylene fasteners are proprietary and function only with the EGS delivery devices. The delivery devices use either a stainless steel helix or suction to grasp tissue and fasten it using the SerosaFuse polypropylene fasteners. The fastener delivery subsystem comprises 3 elements: stylet, pusher, and a lumen. They run the length of the device, the pusher being a hollow tube that rides over the length of the stylet, both riding in the lumen. The stylet is sharp at the distal tip to pierce tissue. The fastener is loaded by snapping it onto the stylet in the loading port of the handle. When pushed by the operator, the stylet carries 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.