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The APOLLO ESG and ESG SX Systems are intended to be used by trained gastroenterologists or surgeons that perform bariatric procedures to facilitate weight loss by reducing stomach volume through endoscopic sleeve gastroplasty in adult patients with obesity with BMI 30 -50 kg/m2 who have not been able to lose weight, or maintain weight loss, through more conservative measures. The APOLLO REVISE and REVISE SX Systems are intended to be used by trained gastroenterologists or surgeons that perform bariatric procedures to facilitate weight loss in adult patients with obesity with BMI 30 - 50 kg/m² by enabling transoral outlet reduction as a revision to a previous bariatric procedure.

Endoscopic Sleeve Gastroplasty (ESG) is an endoscopic procedure that involves the creation of plications in the stomach to reduce stomach volume. The plications form a sleeve, which reduces stomach capacity and slows gastric emptying. Patients having previous Roux-en-Y gastric bypass bariatric surgery may experience dilation of the gastrojejunostomy outlet and the gastric pouch, followed by weight gain. This can be addressed by reducing the diameter of the gastric outlet by suturing. This procedure is often referred to as Transoral Outlet Reduction (TORe). The APOLLO ESG and APOLLO REVISE Systems are designed to accomplish ESG and TORe, respectively, using a dual channel scope. The APOLLO ESG SX and APOLLO REVISE SX Systems are designed to accomplish ESG and TORe. respectively, using a single channel endoscope. The systems function by delivering the suture to the targeted area to create full thickness bites when approximating soft tissue. The device components are: - The OverStitch (SX) Handle is comprised of a needle driver assembly and anchor exchange. - The Tissue Helix enables the user to manipulate and position tissue before and after suturing. - The Suture Anchor consists of a polypropylene suture attached to a metal piece. - The Cinch device is a plastic component that simultaneously cuts the suture and clamps onto the suture.

The X-Tack™ Endoscopic HeliX Tacking System is intended for approximation of soft tissue in minimally invasive gastroenterology procedures (e.g. closure and healing of ESD/EMR sites, and closing of fistula, perforation or leaks). X-Tack is not intended for hemostasis of acute bleeding ulcers.

The X-Tack™ Endoscopic HeliX Tacking System is a sterile, single-use device that enables the user to approximate soft tissue in the gastrointestinal (GI) tract using helix tacks and a 3-0 suture through a 2.8 mm or larger working channel of an endoscope (e.g. gastroscope or colonoscope). OverStitch Suture Cinch The Overstitch Suture Cinch device is comprised of thermoplastic and stainless steel materials and includes an implantable PEEK Cinch component designed to secure and cut the suture once tissue approximation is complete. It is the final step of the X-Tack procedure. The device functions by squeezing the handle and deploying the PEEK components, which form a press-fit onto the tail end of the suture to maintain suture position in situ.

To be used in conjunction with an endoscope for foreign body removal or endoscopic procedures requiring multiple insertions of the endoscope into the lower or upper gastrointestinal tract.

The OverTube™ Endoscopic Access System is comprised of a single, polymer extrusion shaft reinforced with a metallic coil. The hub located at the proximal end of the device contains a cuff seal which can be inflated with air using a syringe to reduce loss of pressure when insufflation is used. The device is available in a single effective length of 27 cm with a tapered distal tip. The OverTube™ Endoscopic Access System will be delivered in a manner that a clinician may open one (1) OverTube per clinical procedure. The OverTube™ Endoscopic Access System will be provided in both sterile and non-sterile models. The sterile model is terminally sterilized by ethylene oxide (EO).

The SuMO™ Access and Tissue Resection System is intended to access, dissect, and resect soft tissue in endoscopic gastrointestinal procedures such as removal of flat polyps. The Injection Needle is intended for endoscopic injection of solutions such as a procedural aid in endoscopic procedures. The Tunneling Balloon is intended for soft tissue separation and dilation during endoscopic procedures. The Dilation Balloon is intended for soft tissue separation and dilation during endoscopic procedures. The Tissue Resection Tool is intended for endoscopic resection in the gastrointestinal tract. The SuMO™ Snare is intended to remove polyps and small tumors from the gastrointestinal tract.

The Apollo Endosurgery SuMO Access and Tissue Resection System is a single-use system intended to access, dissect, and resect soft tissue in endoscopic gastrointestinal procedures. The system is comprised of five component devices: - Injection Needle ● - Tunneling Balloon . - Dilation Balloon . - Tissue Resection Tool . - SuMO Snare ●

The Gastric Port is intended to be used with an endoscope to facilitate intubation of the endoscope as a guide for various flexible endoscopic instruments for intraluminal procedures. The safety and effectiveness of this device for Natural Orifice Transluminal Endoscopic Surgery (NOTES) has not been demonstrated.

Gastric Port Models GAP-0016-00, GAP-0018-00, GAP-0020-00

The Apollo Endosurgery Endoscopic Monopolar Scissors are designed to cut, dissect, and cauterize tissue during flexible endoscopic procedures.

The Endoscopic Monopolar Scissors is comprised of a flexible metal shaft with a distal mounted scissors which is operated by a proximal handle. The proximal handle also has connections for a monopolar electrocautery source. The scissor blades function as standard scissors for mechanical cutting and for standard electrosurgical cutting, as required.

The Electrocautery Dilation Balloon is intended for dilation of strictures of the esophagus and gastrointestinal tract and cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures.

The Electrocautery Dilation Balloon is indicated for dilation of strictures of the esophagus and gastrointestinal tract and cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures. Using either endoscopic or fluoroscopic means, the balloon is placed at the physician selected site. Once in place, the clinician inflates the balloon to dilate the stricture. The electrocautery needle knife may be used for cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures. The needle knife is advanced and retracted with the proximal handle.

The Apollo Endosurgery OverStitch Endoscopic Suture System is intended for endoscopic placement of suture(s) and approximation of soft tissue.

The Apollo Endosurgery OverStitch Endoscopic Suture System provides physicians the ability to perform several different types of tissue apposition within the Gastrointestinal (GI) Tract and peritoneal cavity. Additionally, the system allows the surgeon to 'reload' the suture without the need for removing the endoscope.