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The Esophageal Stent System is intended for maintaining esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistula.

The Esophageal Stent System consists of a self-expanding metal stent and a stent introduction system. The stent is provided pre-loaded in the introduction system. The handle allows for desheathing to deploy the stent and resheathing recapturing the stent during stent deployment. The stent is woven from nitinol wire. The stent is formed with a flange at either end. The increased diameter of the stent ends helps provide resistance to migration. A silicone membrane applied to the stent covers the complete body of the stent along with part or fully of both flanges. The covering is intended to reduce the risk of tissue ingrowth and provides a seal for esophageal fistulas. To aid in visibility under fluoroscopy there are four bands at either end of the stent. The stent has a lasso loop which can be used to reposition the stent during the initial placement procedure if desired. The device is supplied sterile, intended for single use only and is available for prescription use only. Use of this device is restricted to a trained healthcare professional.

The Endoscopic Ultrasound Aspiration Needle is designed to sample targeted submucosal and extraluminal gastrointestinal lesions through the accessory channel of suitable ultrasound videoendoscope in adult patients only.

The proposed Endoscopic Ultrasound Aspiration Needle is a sterile single-use device, designed to sample targeted submucosal and extraluminal gastrointestinal lesions through the accessory channel of suitable ultrasound videoendoscope. It consists of three parts, Aspiration Needle, Syringe and Stopcock. The aspiration needle is offered with multiple types with different dimension, needle tip design and needle material. Syringe and stopcock are accessories to provide and control the vacuum suction to aspirate the sample. There are 12 specifications, the difference is the diameter, material and tip design of needle. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10t and placed in a sterility maintenance package to ensure a shelf life of 2 years.

The LuminScan(TM) Imaging System is is indicated for use as an imaging tool in the evaluation of human tissue microstructure by providing two dimensional, cross sectional, real-time depth visualization.

LuminScan™ Imaging System is a general imaging system comprised of LuminScan™ Imaging System Console and LuminScan™ Disposable Imaging Kit.

The Sterile Repositionable Hemostasis Clipping Device is indicated for endoscopic clip placement within the gastrointestinal tract 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, (3) as a supplementary method, closure of Gl tract luminal perforations <20mm that can be treated conservatively.

The proposed device Sterile Repositionable Hemostasis Clipping Device is a sterile, single-use endoscopic clipping device, intended to be used for endoscopic marking, hemostasis for mucosal/submucosal defects in digestive tract. It consists of two main components, delivery system and clip assembly. And it is offered in different dimensions.