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The Endoscopic Water Pump is a peristaltic pump intended to supply fluid to compatible endoscopes or endotherapy devices for irrigation of the gastric and colonic mucosa during endoscopic or endotherapeutic procedures, allowing to aid in visualisation, diagnosis and treatment.

AGS's Endoscopic Water Pump comprises: - A host machine (including drive system, peristaltic pump head, housing, etc.); - - Operating component (Rotatable Knob and Footswitch); - - -Hanger assembly(optional); - -An irrigation tube (optional) The Endoscopic Water Pump is a motorized pump designed to transfer water from a bottle, via a tube, to an endoscope or EndoTherapy devices, and the pump is operated by a footswitch. It uses a peristaltic pump head to move the water through the tube. The speed of the rotation of the pump head is adjustable by the user, using flow control knob on the front of the pump.

The Sphincterotome is indicated for use in the cannulation of the biliary ducts and the transendoscopic sphincterotomy of the Papilla of Vater and/or the Spincter of Oddi. The device is supplied sterile and intended for single use only.

The Sphincterotome described in this submission is a sterile, single use device compatible with the working channel of endoscope. The device consists of a long plastic tube with a wire running the length of its interior. A small portion of that wire is exposed at its distal end. The roof of papilla is opened by passing high-frequency current through the wire, exposing the biliary or pancreatic orifices for selective cannulation. For non-exchangeable models, the sphincterotome is compatible with endoscopes with a working channel diameter not less than 2.8mm, and the recommended guide wire OD is 0.63mm (0.025inch) or 0.89mm (0.035inch); For normal exchangeable models, there is a small hole on the sheath which is about 200mm far away from the distal end, it is used to insert the guide wire rapidly, the sphincterotome is compatible with endoscopes with a working channel diameter not less than 3.7mm, and the recommended guide wire OD is 0.63mm (0.025inch) or 0.89mm (0.035inch); For C-type exchangeable models, there is an open channel on the sheath to rapid exchange the guide wire, the sphincterotome is compatible with endoscopes with a working channel diameter not less than 3.7mm, and the recommended guide wire OD is 0.63mm (0.025inch) or 0.89mm (0.035inch); For 50910, 50913, 50916 and 50917 series, there's preloaded guide wire, the sphincterotome is compatible with endoscopes with a working channel diameter not less than 3.7mm, and the OD of preloaded guide wire is detailed in the device's label.

Polypectomy Snare is used endoscopically in the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the gastrointestinal tract.

Polypectomy Snare described in this submission is a sterile, single use devices compatible with the working channel of endoscope. The device is used endoscopically in the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the gastrointestinal tract. The device can remove the specified released Hemoclip. EO sterilization and use for single use only.

The Hemoclip is indicated for endoscopic clip placement within the digestive 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 of digestive tract luminal perforations<20mm that can be treated conservatively.

Hemoclip consists of Release part and Clip part. Clip part consists of Clip and Frap Tube. Release part consists of Spring End, Spring hose near clip end, Connect end, Plastic Coated Spring Tube / Spring Tube and Handle part. EO Sterilization and use for single use only. For our proposed Hemoclip, the release part could connect and release the clips repeatedly. We include 5 series for this submission, 55501series, 55502 series, 55504 series and 55505 series. 55501 series and 55502 series are models consist of release part and clip part, and the release part and clip part are already combined, no additional separate clips include, 55501series and 55502 series are reloadable, the release part could connect and release clips repeatedly. 55503 series are models only consist of separate clip part, and the release part of 55501, 55502, 55503 and 55504 series can connect with the separate clip (55503 series) repeatedly. 55504 and 55505 series are models consist of one preloaded Hemoclip (consist of release part and clip part, and the release part and clip part are already combined) and additional separate clips, 55504 series and 55505 series are reloadable, the release part can connect separate clips and release clips repeatedly.

The Balloon Dilatation Catheter is intended to endoscopically dilate strictures of the alimentary tract. The device is supplied sterile and intended for single use only.

The proposed device Balloon Dilatation Catheter is comprised of a pebax balloon mounted at the distal end of a pebax catheter with two ports. The balloon can be inflated to three distinct sizes, 6-7-8mm, 8-9-10mm, 10-11-12mm, 12-13.5-15mm, 15-16.5-18mm, 18-19-20mm diameters; the balloon length can be 30mm, 55mm and 80mm. Radiopaque bands placed at the distal and proximal end of the device provide fluoroscopic visualization of the balloon location. The catheter length is 1800mm, 1950mm, 2100mm and 2400mm with an outer diameter of 1.8mm, 2.0mm or 2.3mm. The two ports correspond to a guide wire port and balloon inflation port. A stopcock is included at the proximal end of the balloon inflation port to control pressure movement into or out of the device. For rapid exchange models, there is a small hole on the catheter which is about 200mm far away from the distal end, it is used to insert the guide wire rapidly. The Balloon Dilatation Catheter is EO sterilization and use for single use only.

The Hemoclip 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 - 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 of GI tract luminal perforations<20mm that can be treated conservatively.

Hemoclip consists of Release part and Clip part. Clip part consists of Clip and Frap Tube. Release part consists of Spring End, Plastic Coated Spring Tube / Spring Tube and Handle. EO Sterilization and use for single use only. For 510 family, the grooves on the frap tube allow the released clip could be removed by snare loops. If the clip has been deployed, but its position is not satisfactory, or it affects the field of vision, we can remove it.

Bipolar Coagulation Forceps have been designed to be used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract.

The Bipolar Coagulation Forceps described in this submission are a sterile, single use devices compatible with the working channel of endoscope. The device is used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract. Bipolar Coagulation Forceps consists of Handle part, plug, sheath and forceps part.

The Sphincterotome is indicated for use in the cannulation of the biliary ducts and the transendoscopic sphincterotomy of the Papilla of Vater and/or the Spincter of Oddi. The device is supplied sterile and intended for single use only.

The sphincterotome described in this submission are a sterile, single use devices compatible with the working channel of endoscope. The device consists of a long plastic tube with a wire running the length of its interior. A small portion of that wire is exposed at its distal end. The roof of the papilla is opened by passing high-frequency current through the wire, exposing the biliary or pancreatic orifices for selective cannulation. For 50910 series, there's preloaded guide wire.

This device is an accessory to be used with endoscopic biliary devices to lock the guidewire(s) in place during ERCP procedure. The device is supplied sterile and intended for single use only.

The proposed Locking Device is one-piece integrated system that secures onto the accessary channel of an endoscope. The access port in the center of the cap allows access of wire guides and other biliary accessories. The wire guide lock allows the practitioner to lock the wire guide in place for continued ductal access while proceeding with other ERCP therapies. This device consists of locking device and biopsy cap.

The device is used for the endoscopic removal of biliary stones and foreign bodies.

The subject Disposable Stone Extraction Basket is comprised of a stainless steel/nitinol basket at the distal end of a sheath with handle. Basket is advanced out of and retracted into the single lumen polytetrafluoroethylene catheter sheath using the handle component's actuator. The device is not compatible with any mechanical lithotripter. EO Sterilization and use for single use only.