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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.

Disposable Endoscope Injection Needles are used with endoscope to perform endoscopic vascular or submucosal injection in the GI tract.

The Disposable Endoscope Injection Needles consist of a Sliding handle, Handle, Cap, Sheath, Inner Tube, Guide Tube, Connecting tube, and Tip (only Type B). It is available in a variety of configurations with varying needle lengths, gauges and working lengths. Type A and Type B are included in this submission.

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

The Disposable 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. The models with injection can inject contrast medium into the biliary ducts. The main materials of the proposed device include PTFE, ABS, SUS304. Type A, Type B and Type C are included in this submission. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and placed in a sterility maintenance package to ensure a shelf life of 3 years.