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The PADLOCK CLIP™ EFTR Device is an electrosurgical device that is designed for a flexible endoscope. It is intended for diagnostic tissue acquisition and full thickness resection through the removal of lesions in the colon and rectum. The PADLOCK CLIP™ EFTR Device is indicated for the resection of lesions less than 3cm in the colon and rectum. Resection sizes may be less than 3cm due to targeted tissue thickness and degree of fibrosis. The disposable RAPTOR Grasping Device is intended to be used to grasp tissue and/or retrieve foreign bodies, excised tissue and stents during endoscopic procedures. The TOUCHSOFT Coagulator is used to provide monopolar therapeutic hemostasis and tissue ablation in the gastrointestinal tract through a flexible endoscope by a trained physician or clinician.

The PADLOCK CLIP Endoscopic Full Thickness Resection (EFTR) Device is an electrosurgical, single use tissue resection system. The system is part of a kit that consists of a preloaded, radiopaque, Super Elastic NiTi (Nitinol) single use clip within a mechanical delivery system along with a preloaded snare for tissue resection. The PADLOCK CLIP EFTR Device is mounted over the distal tip of a flexible endoscope. The linking cables run along the outside of the endoscope and are attached to the handle. The PADLOCK CLIP EFTR Device includes a tissue chamber that resides on the distal tip of the endoscope. The kit's two additional devices, the TOUCHSOFT Coagulator Monopolar Single Use Device, and RAPTOR Grasping Device are used in conjunction with the PADLOCK CLIP EFTR Device through the flexible endoscope's accessory channel. The TOUCHSOFT Coagulator Monopolar Single Use Device (ablation device) will be used to mark a lesion by ablating the lesion's perimeter, thereby indicating the area for resection. Instructions for Use for the TOUCHSOFT Coagulator Monopolar Single Use Device are included within the kit. The RAPTOR Grasping Device will be used to grasp and retract the target lesion into the tissue chamber. Instructions for Use for the RAPTOR are included within the kit. These devices are used for colorectal lesions that would otherwise not be resectable by standard polypectomy techniques. The PADLOCK CLIP EFTR Device includes a resection clip made of super elastic nitinol and a snare made of stainless steel. The PADLOCK CLIP EFTR Device also includes handle components molded from ABS material, Stainless Steel drive wires, HDPE catheter, and a scope attachment assembly made of TPE and Polycarbonate.

The Resolution™ Clip is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of: 1. Endoscopic marking 2. Hemostasis for: - Mucosal/sub-mucosal defects < 3 cm - Bleeding ulcers · Arteries < 2 mm - Polyps < 1.5 cm in diameter - · Diverticula in the colon - Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection 3. Anchoring to affix jejunal feeding tubes to the wall bowel; and Anchoring to affix fully covered esophageal self-expanding metal stents to the wall of the esophagus 4. As a supplemental closure method of luminal perforations < 20 mm that can be treated conservatively.

The Resolution™ Clip is a sterile device consisting of a pre-loaded, radiopaque, single-use, endoscopic clipping device consisting of two main components: the delivery system and the clip. The delivery system consists of a handle assembly and delivery catheter. The clip delivery system is offered in a 155cm and 235cm working length. The clip consists of a stainless-steel capsule and clip arms, a cobalt chrome yoke, and a styrene tension breaker. The clip is deployed from the delivery system during use. The clip jaws are engineered such that they can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site. Re-opening and closing may be limited by clinical circumstances and patient anatomy, among other factors. The Resolution™ Clip is designed to be compatible with endoscopes with working channels equal to or greater than 2.8 mm. There are no associated accessories included with this device.

The The Haemostasis Clips are indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of: 1. Endoscopic marking. 2. Hemostasis for: Mucosal/sub-mucosal defects <3cm; Bleeding ulcers; Arteries<2mm; Polyps<1.5cm in diameter; Diverticula in the colon; Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection. 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel; 4. As a supplementary method, closure for GI tract luminal perforations<20mm that can be treated conservatively.

The Haemostasis Clips are sterile devices consisting of a pre-loaded, radiopaque, single-use, endoscopic clipping device consisting of two main components: the delivery system and the clip part. The delivery system consists of a handle assembly and delivery catheter assembly. The delivery system is constructed using stainless steel and polyester materials. The delivery system will allow for the device to rotate at the distal end. The delivery system is offered in 1650mm, 1950mm and 2350mm working lengths. The clip part consists of a stainless steel tightening capsule, movable pin and clip arms. The clip is deployed from the delivery system during use. The hemoclip jaws are engineered such that they can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site. Re-opening, closing, and rotation capability may be limited by clinical circumstances and patient anatomy. There are no associated accessories included with this device.

The PADLOCK CLIP™ EFTR Device is a device that is designed for a flexible endoscope. It is intended for diagnostic tissue acquisition and full-thickness resection through the removal of lesions in the colon and rectum. The PADLOCK CLIP™ EFTR Device is indicated for the resection of lesions less than 3cm in the colon and rectum. Resection sizes may be less than 3cm due to targeted tissue thickness and degree of fibrosis. The disposable RAPTOR Grasping Device is intended to be used to grasp tissue and/or retrieve foreign bodies, excised tissue and stents during endoscopic procedures. The TOUCHSOFT Coagulator is used to provide monopolar therapeutic hemostasis and tissue ablation in the gastrointestinal tract through a flexible endoscope by a trained physician or clinician.

The PADLOCK CLIP Endoscopic Full Thickness Resection (EFTR) Device is an electrosurgical, single use tissue resection system. The system is part of a kit that consists of a preloaded, radiopaque, Super Elastic NiTi (Nitinol) single use clip within a mechanical delivery system along with a preloaded snare for tissue resection. The PADLOCK CLIP EFTR Device is mounted over the distal tip of a flexible endoscope. The linking cables run along the outside of the endoscope and are attached to the handle. The PADLOCK CLIP EFTR Device includes a tissue chamber that resides on the distal tip of the endoscope. The kit's two additional devices, the TOUCHSOFT Coagulator Monopolar Single Use Device, and RAPTOR Grasping Device are used in conjunction with the PADLOCK CLIP EFTR Device through the flexible endoscope's accessory channel. The TOUCHSOFT Coagulator Monopolar Single Use Device (ablation device) will be used to mark a lesion by ablating the lesson's perimeter, thereby indicating the area for resection. Instructions for Use for the TOUCHSOFT Coagulator Monopolar Single Use Device are included within the kit. The RAPTOR Grasping Device will be used to grasp and retract the target lesion into the tissue chamber. Instructions for Use for the RAPTOR are included within the kit. These devices are used for colorectal lesions that would otherwise not be resectable by standard polypectomy techniques. The PADLOCK CLIP EFTR Device includes a resection clip made of super elastic nitinol and a snare made of stainless steel. The PADLOCK CLIP EFTR Device also includes handle components molded from ABS material, Stainless Steel drive wires, HDPE catheter, and a scope attachment assembly made of TPE and Polycarbonate.

The BARS Set is indicated for clip placement within the context of flexible endoscopy in the GI tract for the purpose of: - Hemostasis for: - Mucosal/submucosal defects < 3 cm - Arteries < 2 mm - Treatment of luminal perforations (< 20 mm) and / or anastomoses (< 50 mm) - Lumen reduction NOTE: The BARS Set is not indicated for stent fixation, For stent fixation, use the stentfix OTSC System Set.

The subject device constitutes an over-the-scope clip application device used within the context of flexible endoscopy in the gastrointestinal tract. The over-the-scope clip application capabilities center around a memory-shape alloy clip mounted on a transparent plastic cap. Cap (and clip) are mounted on the distal end of an endoscope. Endoscopic instruments are provided in the BARS Set to facilitate insertion and for mobilization of target tissue into the cap lumen. With the target tissue inside the cap lumen, the memory-shape alloy clip is applied onto the target tissue using a thread mechanism. Contents of the BARS Set are: - BARS (readily assembled unit of memory-shape alloy clip, transparent plastic cap, thread deployment components, working channels, and guide elements) - Endoscopic instruments (BARS Anchor silver, BARS Anchor black, Insertion Balloon, Space Keeper Balloon, Guide Wire)

The device is used for endoscopic clip placement within the gastrointestinal(GI) tract for the purpose of endoscopic marking, hemostasis for mucosal/submucosal defects less than 3cm, bleeding ulcers, arteries less than 2mm, polyps less than 1.5cm in diameter and diverticula in the colon. Anchoring to affix jejunal feeding tubes to the wall of the small bowel. Closure of Gl tract lumenal perforations less than 20mm that can be treated conservatively.

The Single Use Hemoclip is a sterile, single use device that consists of metal clip that detaches from the introducer to maintain approximation of tissue to achieve hemostasis and endoscopic marking in the gastrointestinal tract. The device is provided sterile (EO). The large clip opening design meets various clinical treatment demands. It can be opened and closed repeatedly and can achieve repositioning. The 360 rotatable design is convenient for clinical use. lt consists of two main components, delivery system and clip assembly. And it is offered in different dimensions.

The Disposable Hemostatic Clips is indicated for Endoscopic clip placement within the Gastrointestinal tract in adult populations only via a straight or side viewing flexible endoscope for the purpose of : 1) Endoscopic marking; 2) Hemostasis for: A) Mucosal/sub-mucosal defects < 3cm. B) Bleeding ulcers. C) Polyps < 1.5cm in diameter. D) Diverticula in the colon. E) Arteries < 2 mm. F) Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection. 3) As a supplementary method, closure of GI tract luminal perforations <20mm that can be treated conservatively 4) Anchoring to affix jejunal feeding tubes to the wall of the small bowel

The proposed device is consisted of a clip section. The delivery section. The delivery section include: slide bar, slip ring, protective sleeve, rotation head, coated spring tube, slip ring holder, traction assembly, connecting tube, decoupled piece, decoupled shrapnel, rotation sleeve. And the clip section include: clip, sliding block, shaft and rocker arm. The clip is made of stainless steel. The clip can be opened and closed more than five times prior to deployment, aiding in repositioning of the lesion site. The proposed device is available in single ring and three ring models, and each case is divided into rotatable and non-rotatable clip. The effective length of the proposed device includes 1250mm, 1650mm, 2350mm and the opening width is 9mm, 11mm. 13mm and 16mm. The proposed devices are provided in sterile and single use.

The Single Use Reloadable Clip Applicators HX-810 Series, Long Clip HX-610 Series, Short Clip HX-610 Series and Super Short Clip HX-610-135XS have been designed to be used with an Olympus endoscope for endoscopic Clip placement within the gastrointestinal (GI) tract in adult patients only for the purpose of: (1) Endoscopic marking, (2) Hemostasis for (a) Mucosal/sub-mucosal defects < 3 cm, (b) Bleeding ulcers, (c) Arteries < 2 mm, (d) Polyps < 1.5 cm in diameter, (e) Diverticula in the colon, (3) As a supplementary method, closure of Gl tract luminal perforations < 20 mm that can be treated conservatively.

The instruments (AKA EZClip) have been designed to be used with an Olympus endoscopic Clip placement within the gastrointestinal (GI) tract in adult patients only for the purpose of: (1) Endoscopic marking, (2) Hemostasis for (a) Mucosal/sub-mucosal defects < 3 cm, (b) Bleeding ulcers, (c) Arteries < 2 mm, (d) Polyps < 1.5 cm in diameter, (e) Diverticula in the colon, (3) As a supplementary method, closure of Gl tract luminal perforations < 20 mm that can be treatively. The Single Use Reloadable Clip Applicators and Clips are single-use devices. The HX-810 series Applicators are sterilized by Ethylene Oxide Gas and the HX-610 series Clips are sterilized by Gamma-ray radiation. The Single Use Reloadable Clip Applicators and Clips are used in a combined state. The clip connected to the hook portion of the applicator is controlled via operation wire by the slider. The clip protruded from the coil sheath opens to the maximum opening width when the slider of the applicator is pulled towards the operator. Clipping is achieved when the slider of the applicator is pulled completely and the clip connector is broken. Upon completion, the clip and the applicator are no longer connected. Once the clipping is performed, the closure force of clips remains in place until tissue necrosis occurs, and the clip is excreted naturally.

The Disposable Dual Action Tissue Closure Device is intended for use in flexible endoscopy for the compression of tissue in the gastrointestinal tract for adult patient only. The Disposable Dual Action Tissue Closure Device is indicated for clip placement within the gastrointestinal tract for the purpose of: 1. Endoscopic marking: 2. Hemostasis for: a.Mucosal/sub-mucosal defects < 5 cm, b.Bleeding ulcers, c.Polyps < 1.5 cm in diameter, d.Diverticula in the colon, e. Arteries < 2 mm, 3. As a supplementary method. closure of GI tract luminal perforations < 20 mm that can be treated conservatively.

The proposed device Disposable Dual Action Tissue Closure Device is a sterile, single-use endoscopic clipping device, intended to be used in flexible endoscopy for the compression, manipulation of tissue in the gastrointestinal tract. It consists of two main components, delivery system and clip assembly. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 106 and placed in a sterility maintenance package to ensure a shelf life of 3 years.

The Disposable Hemostatic Clips is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of: 1.Endoscopic marking 2. Hemostasis for: Mucosal/sub-mucosal defects <3cm Bleeding ulcers Arteries<2mm Polyps<1.5cm in diameter Diverticula in the colon 3.Anchoring to affix jejunal feeding tubes to the wall of the small bowel 4.As a supplementary method, closure for Gl tract luminal perforations<20mm that can be treated conservatively.

The Disposable Hemostatic Clips consist of one pre-loaded clip and delivery system for single patient use only. It is provided in sterile. The clip is made of stainless steel with good superelasticity performance. The clip is pre-loaded in end of the Spring tube part through its deformation and it is deployed from the delivery system during use.The clip is engineered such that they can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site. The device is available in four clip opening widths, which are 9mm, 11mm, 13mm and 16mm, and the device effective length is available in 1650mm, 1950mm and 2300mm.