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Disposable Distal Cap is used with the endoscope and installed to the distal end of endoscope to keep appropriate endoscopic field of view.

Disposable Distal Cap is used with the endoscope and installed to the distal end of endoscope to keep appropriate endoscopic field of view. Disposable Distal Cap is a single structural product, a total of 3 types, and each type is divided into different specifications according to different inner diameter and the diameter of attaching endoscopic distal end. 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 one year.

This device is used for the endoscopic removal of stones in the biliary system and foreign bodies.

The proposed device is a sterile, single-use accessory to be used with endoscopic, intended to be used for the removal of stones in the biliary system and foreign bodies. The proposed device includes two types, one type (Hereinafter referred to Type 1) is working through the channel provided by duodenoscopy, cross the duodenal papilla and insert into the bile duct, with the assistance of Imaging field of view formed by X-ray, capture and remove stones out of bile duct. Another one (Hereinafter referred to Type 2) is working through the channel provided by choledochoscope, after the choledochoscope was inserted into the bile duct successfully, inserted the extraction basket into the bile duct by the channel of choledochoscope, capture and remove stones out of bile duct by the direct field view of choledochoscope. The proposed device is EO sterilized to achieve the Sterility Assurance Level (SAL) of 106 and placed in a sterility maintenance package to ensure a shelf life of 1 year for Type 1 and 3 years for Type 2.

The Biliary Plastic Stent is used to drain obstructed biliary ducts. The Biliary Plastic Stent Introducer is used for endoscopic biliary stent placement. The Biliary Plastic Stent Introducer/ short-wire compatible is used for endoscopic biliary stent placement. The Biliary Plastic Stent Set is intended for endoscopic biliary stent placement to drain obstructed bile ducts. The Biliary Plastic Stent Set short-wire compatible is intended for endoscopic biliary stent placement to drain obstructed bile ducts.

The proposed device Biliary Plastic Stent Set is a sterile, single-use endoscopic device, the device is used to drain obstructed biliary ducts. Biliary Plastic Stent Set includes Biliary Plastic Stent (hereafter referred as Category 1), Biliary Plastic Stent Introducer (hereafter referred as Category 2), Biliary Plastic Stent Set (hereafter referred as Category 3), Biliary Plastic Stent Introducer/ short-wire compatible (hereafter referred as Category 4) and Biliary Plastic Stent Set/ short-wire compatible (hereafter referred as Category 5). Category 3 is commonly used in traditional ERCP (short for endoscopic retrograde cholangiopancreatography) surgery with a long guidewire (4.5m) while Category 4 and Category 5 adopts short-wire design which is compatible with a short guidewire (2.6m). For specifications of Category 4 and Category 5, the main feature of the short wire design is the guide wire exit port on the inner tube of the introducer which is used to separate guidewire from the proposed device (For Biliary Plastic Stent Introducer (Normal), the guide wire exit on the inner tube; for Biliary Plastic Stent Introducer (Pusher), the guide wire exit on the outer tube). The guidewire can be locked in place using Guidewire Locking Device to maintain guidewire access. Then the exchange of various devices can be performed without concern over wire displacement. There are 66 specifications of Category 1 which mainly differ in plastic stent shape (side bend, center bend, double pigtails), plastic stent diameter (7Fr, 8.5Fr, 10Fr, 11.5Fr) and plastic stent working length (3cm-18cm). There are 4 specifications of Category 2 which mainly differ in introducer diameter (7Fr, 8.5Fr, 10Fr, 11.5Fr) and can be divided into two types including Biliary Plastic Stent Introducer (Normal) and Biliary Plastic Stent Introducer (Pusher) depending on whether with or without inner tube assembly. There are 66 specifications of Category 3, each specification contains both plastic stent and introducer. The plastic stent in Category 3 is the same as that in Category 1, which mainly differ in plastic stent shape, plastic stent diameter and plastic stent working length, the introducer in Category 3 is the same as that in Category 2, which includes Biliary Plastic Stent Introducer (Normal) and Biliary Plastic Stent Introducer (Pusher). Among them, the plastic stent with a diameter of 7Fr in Category 3 corresponds to Biliary Plastic Stent Introducer (Pusher), and the rest correspond to Biliary Plastic Stent Introducer (Normal). There are 3 specifications of Category 4 which mainly differ in introducer diameter (7Fr, 8.5Fr, 10Fr) and can be divided into two types including Biliary Plastic Stent Introducer/ short-wire compatible (Normal) and Biliary Plastic Stent Introducer/ short-wire compatible (Pusher) depending on whether with or without inner tube assembly. There are 54 specifications of Category 5, each specification contains both plastic stent and introducer/ short-wire compatible. The plastic stent included in Category 5 is the same as that (except 11.5Fr diameter) in Category 1, the introducer short-wire compatible in Category 5 is the same as that in Category 4, which includes Biliary Plastic Stent Introducer/ short-wire compatible (Normal) and Biliary Plastic Stent Introducer/ short-wire compatible (Pusher). Among them, the plastic stent with a diameter of 7Fr in Category 5 corresponds to Biliary Plastic Stent Introducer/ short-wire compatible (Normal), and the rest correspond to Biliary Plastic Stent Infroducer/ short-wire compatible (Pusher). 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. They have an indicated indwell of up to 3 months

The Elastic Traction System is indicated for adult only for use in flexible Endoscopy to provide retraction to assist in tissue resection, exposure, and removal of tissue within the stomach and colon.

The proposed device, Elastic Traction System, consists of 2 components, an Elastic Traction Device, and a clipping device (Fig. 1). Two components are single use device. The Elastic Traction Device is a single use tissue traction device. It is consisting of clip assembly, silicone band and delivery system. The silicone band is consisting of three rings. Ring A is preloaded with the clip. The Clipping Device is a single use device, and its purpose is to use it as a second clip. The second clip is used to engage the silicone band of the previously anchored clip of Elastic Traction Device.

The Endobronchial Ultrasound Aspiration Needle is used with ultrasound endoscope to sample targeted submucosal and extramural lesions of the tracheobronchial tree.

The proposed device Endobronchial Ultrasound Aspiration Needle is a sterile, single-use bronchoscopic device, is designed to sample targeted submucosal and extramural lesions of the tracheobronchial tree. The Endobronchial Ultrasound Aspiration Needle consists of an Aspiration Needle, Adaptors and Negative suction device (Stopcock and Syringe). Wherein, the Aspiration Needle consists of a handle, sheath, needle, and stylet. The handle is connected to the channel port of a bronchoscope via the proper adaptor. The needle is deployed in the sheath and projected from the sheath to penetrate the target lesion to serve sample by advancement of handle. The stylet is in place in order to provide protection to the inside of the needle tube and sheath during device passage, and also used to expel the sample after the procedure. The adaptors are provided different bronchoscopes with compatibility and attached onto the channel port as the middleware between a bronchoscope and the aspiration needle. The negative suction device is connected to the proximal end of the handle to aspirate the removed tissue. The Endobronchial Ultrasound Aspiration Needle has echogenic features and is visible under ultrasound at the distal end to facilitate real time visualization of the device under ultrasound. The proposed device has six models, and the main differences of these models are diameter and tip type of the needle. The Endobronchial Ultrasound Aspiration Needle offers 19G, 22G, 25G needles by size or gauge to respond various clinical options of accessing and sampling. There are two kinds of different tip design (bevel and trident) of needles for FNA (Fine Needle Aspiration) and FNB (Fine Needle Biopsy). The device is identified as is Areus™ Endobronchial Ultrasound Aspiration Needle and Trident™ Endobronchial Ultrasound Aspiration Needle by trade name. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10th and placed in a sterility maintenance package to ensure a shelf life of 3 years.

The Through the Scope Tracheal Stent System is in the treatment of tracheobronchial strictures caused by malignant neoplasms.

The Through the Scope Tracheal Stent System consists of a flexible delivery system preloaded with a self-expanding implantable metallic stent. The stent is made of Nitinol wire weaved in a tubular mesh shape. This structure may make the stent more flexible, compliant and self-expanding. The stent is fully covered with silicone membrane and a polymer coating. The Parylene N is added on the surface of silicone membrane to restrict tumor in-growth through the wire mesh. A retrieval loop made of PE&PP is threaded through the proximal and distal ends of the stent and is intended to aid in removal during the stent placement procedure. The stent has different dimension with the diameters of 10mm, 12mm, 16mm, 18mm, with the lengths of 20mm, 30mm, 40mm, 50mm, 60mm, 80mm. The stent is deployed through the endoscopy working channel and under direct vision of endoscopy. The delivery system allows for desheathing to deploy and reposition the stent during the placement procedure. The delivery system consists of two coaxial sheaths and one inner core. The outer sheath serves to constrain the stent until being retracted during the stent deployment. The middle sheath serves to support the delivery system. The round tip acts as a guide when the delivery system enters the body. The front handle is used for deploying the stent. The seal ring, locking ring, and safe lock work to lock the device and prevent the stent from being exposed. The decoration nut connects with the back handle. 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 device for flexible endoscopy and for compression of tissue in the gastrointestinal (GI) tract, for for treating gastrointestinal organ wall lesions, and for making of lesions. The Device is indicated for clip placement within the GI tract for the purpose of: a .Endoscopic Marking b. Hemostasis for: - Mucosal/Submucosal defects < 3cm - Bleeding Ulcers - Arteries <2 mm - Polyps < 1.5 cm in diameter - Diverticula in the Colon c. Closure of GI tract luminal perforations < 20mm that can be treated conservatively.

The Disposable Hemostatic Closure Clip Device is a sterile, single-use endoscopic clipping device, intended for flexible endoscopy and for compression of tissue in the gastrointestinal (GI) tract, for hemostasis or for treating gastrointestinal organ wall lesions, and for making of lesions. The device is indicated for clip placement within the GI tract for the purpose of. a. endoscopic marking b. hemostasis for: - mucosal/submucosal defects < 3cm - bleeding ulcers - arteries < 2 mm - polyps < 1.5 cm in diameter - diverticuli in the colon C. Closure of GI tract luminal perforations < 20mm that can be treated conservatively. The Disposable Hemostatic Closure Clip Device consists of one pre-loaded clip and delivery device for single patient use only. The clip is made of nickel-titanium alloy with good superelasticity performance. The clip is pre-loaded in the barrel at the end of the delivery system through its deformation. The proposed device has twenty-four (24) specifications that vary to the outer diameter of the clip: φ14.5 mm, φ17.0 mm; working length: 1650 mm, 1950 mm, 2350 mm, 2700 mm; and whether the outer tube is coated or not. 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.

The Retrieval Balloon Catheter is indicated for use endoscopically to remove stones from biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.

The proposed device Retrieval Balloon Catheter includes Sterile Biliary Stone Retrieval Balloon Catheter (hereafter referred as Category 1) and Retrieval Balloon / short-wire compatible (hereafter referred as Category 2). Category 1 is commonly used in traditional ERCP surgery with a long guidewire (4.5m) while Category 2 adopts short-wire design which is compatible with a short guidewire (2.6m). For specifications of Category 2, the main feature of the short wire design is the C-shaped groove on the sidewall of catheter which is used to separate guidewire from the proposed device. The guidewire can be locked in place using Guidewire Locking Device to maintain guidewire access. Then the exchange of various devices can be performed without concern over wire displacement. The proposed device Retrieval Balloon Catheter is sterile, single-use endoscopic device, and is indicated for use endoscopically to remove stones from biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon. The proposed Retrieval Balloon Catheter is comprised of a natural latex balloon mounted at the distal end of a Pebax catheter with three internal lumens for ballooning, guidewire and contrast medium. The internal lumen for ballooning is used to inflate/deflate the balloon. Multiple syringes are included with the packaging, allowing balloon inflation to a specific diameter. Following insufflation, the balloon surface lies flat against the bile duct wall, enabling efficient and complete cleaning of the bile duct. A separate lumen is designed for a 0.035 inch guidewire and the guidewire is able to be loaded either from the front or the back. Another separate lumen is designed for contrast medium. There are for injection-distal or injection-proximal options offered to support physician preference and facilitate procedural needs. The balloon can be inflated to 9 mm, 12 mm, 15 mm, 18 mm diameters using the pre-measured syringes and a single balloon can be inflated to two or three distinct sizes if a different diameter is needed without having to exchange devices. During stone removal process, the balloon can be filled to removal multiple stones in the biliary tract. There are two radiopaque bands placed at the distal and proximal ends of the balloon providing high fluoroscopic visualization of the balloon location.

The Guidewire Locking Device is an accessory to be used with endoscopic biliary devices to lock the guidewire(s) in place during ERCP procedures.

The Guidewire Locking Device is a sterile, single-use accessory to be used with endoscopic biliary devices, intended to be used to lock the wire guide(s) in place during ERCP procedures. The Guidewire Locking Device is fitted on the duodenoscope to lock the guidewire and plug the working channel access. During the ERCP operation, the device and guidewire can be inserted into the endoscope through the opening of the guidewire locking device, the Guidewire Locking Device can lock up to two guidewires at the same time. During the insertion and exchange of the device, the guidwire can be locked and will not be moved, so the convenience of the operation can be improved. The Guidewire Locking Device is composed with the guidewire locking assembly and the clamp seal assembly. The main materials of the proposed device include ABS, Silicone rubber, SUS304 and Polyurethane sponge. This device should only be used by healthcare professional trained in ERCP. As an accessory of digestive endoscopy, the product shall be used by professionals familiar with the operation technique of digestive endoscopy. There are 2 specifications which mainly differ in adaptive endoscope. MT-RGL-O-N is compatible for Olympus/ Fujinon Duodenoscope, and MT-RGL-P-N is compatible for Pentax Duodenoscope. The proposed device is 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 6 months.

The Disposable Dual Action Tissue Clip 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 Clip is indicated for clip placement within the gastrointestinal tract for the purpose of: Endoscopic marking, Hemostasis for ·Mucosal/sub-mucosal defects < 3 cm, ·Bleeding ulcers, ·Polyps < 1.5 cm in diameter, ·Diverticula in the colon, ·Arteries < 2 mm, As a supplementary method, closure of GI tract luminal perforations < 20 mm that can be treated conservatively.

The proposed device Disposable Dual Action Tissue Clip is a sterile, single-use endoscopic clipping device, intended to be used in flexible endoscopy for the compression 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 10 ° and placed in a sterility maintenance package to ensure a shelf life of 1 year.