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The Disposable Sphincterotome is indicated for use in transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. This device can also be used to cannulate and inject contrast medium.

The subject device Disposable Sphincterotome is a sterile, single-use endoscopic device, intended to be used with flexible endoscopes for intubation of the pancreaticobiliary system and for sphincterotome. The disposable sphincterotome consists of cutting wire, sheath, quide wire connector, injection connector, conductive column, finger ring, handle, and imaging ring. The subject device has 72 specifications. The differences among these models are the Cutting Length, Tip Length, Working Length and Type of guide wire lumen channel. The subject 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 3 years. The main materials used for construction of Disposable Sphincterotome include PTFE, ABS, SUS304.

This instrument has been designed to be used with endoscopes to collect tissue, cauterize, coagulate and perform hemostasis using high-frequency current within the digestive tract.

The subject device Disposable Hot Biopsy Forceps is a sterile, single-use endoscopic device, intended to be used with endoscopes to cut, coagulate and stop bleeding in the digestive tract by using high-frequency current. The disposable Hot Biopsy Forceps consists of an insertion part and a handle part. The insertion part includes a jaw assembly and a spring tube; the handle part includes a handle, a finger ring, a conductive column, a rotating sleeve, a locking sleeve, and a sheath tube. The subject device has 7 specifications. The differences among these models are the jaws type, Jaw O.D, and Working Length. The subject device is EO sterilized to achieve the Sterility Assurance Level (SAL) of 10 ° and placed in a sterility maintenance package to ensure a shelf life of 3 years. The materials used for construction of Disposable Hot Biopsy Forceps are typical for this type of medical device. Materials of Jaw and spring tube is stainless steel SUS304, the Sheath tube is made of HDPE, the Locking sleeve, Rotating sleeve and handle are made of ABS. The conductive column is made of H62.

Disposable Hemoclip is indicated for clip placement within the Gastrointestinal (GI) 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 ) As a supplementary method, closure of GI tract luminal perforations < 20mm that can be treated conservatively.

The clip is pre-installed at the front of the chuck releaser, the chuck releaser is delivered by the conveyor duct through the endoscope to the Gastrointestinal (GI) tract system finds the bleeding site, thumb ring releases the chuck, so that the clip clamps the bleeding site to stop the bleeding. The proposed device is a sterile, single-use endoscopic clipping device. It is consisted of two main components: the delivery system and the HC series. The delivery system is available in three different working length. The clip is deployed from the delivery system during use. The hemoclip jaws can be opened and closed no more than five times prior to deployment, aiding in repositioning of the clip at the lesion site. There are 30 models of Disposable Hemoclip.The main structure and material of each specification model are completely consistent. The outer tube of the plastic wrap type has one more layer of plastic than that of the ordinary type. The material is PE, but the other is the same.

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

The Disposable Polypectomy Snare consists of an insertion part and a handle part. The insertion part includes cutting loop(a flexible wire cable), traction wire, and sheath; the handle part includes sheath sleeve, locking sleeve, rotating sleeve, electrode connector, slider and a handle. The cutting loop can be extended and retracted from the Snare's flexible outer sheath using a three ring handle. The cutting loop can also be rotated 360° using the rotating actuator on the handle. The inner diameter of the sheath is PTFE to provide minimal friction during extension, rotation, and retraction of the loop from the sheath. When passed through an endoscope and activated, the Snare delivers a monopolar electrical current to cut and cauterize tissue with the loop. The Disposable Polypectomy Snare is sterile for single use with no delayed hypersensitivity and no intracutaneous reactivity, have no animal or human origin substance. The cutting loop of disposable polypectomy snare has four shapes to be used in clinical practice: Ellipse type (E type), Hexagonal type (H type), Crescent type (C type), Round type (R type), and the loop can extend, retract from the snare's flexible outer sheath. The materials used for construction of Disposable Polypectomy Snare are typical for this type of medical device. Materials of Cutting Loop is stainless steel 06Cr19Ni10, the Sheath is made of PTEF, the Electrode Connector is made of stainless steel SUS304. The Handle, Slider, Rotating Sleeve and Locking Sleeve are made of ABS, the Sheath Sleeve is made of HDPE.

Used to endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids.

Multi-band ligator inculding control handle (rotation handle, shaft and joint), loading catheter, irrigation adapter (irrigation pipe and base), barrel, trigger cord (cord and pellets) and loop.The barrel preloaded with 4~9 loops. This device is designed for attachment to the end of an endoscope for ligating esophageal varices or hemorrhoids. Once assembled and attached the endoscope is advanced to the desired banding site and individual bands are deployed via manipulation of the deployment handle and trigger cord. The multi-band feature allows for serial ligations, which reduces the need to remove the endoscope for reloading. This device is supplied non-sterile and is intended for single use only.

Single use injection needle is to be used in conjunction with an endoscopic injections, such as for the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract.

Endoscopic Injection Needle consists of Handle, Rod, Needle, Needle holder, Sheath, Catheter, Adapter, Sheath holder, Sheath protection pipe, Tube cap. The Endoscopic Injection Needle is available in three needle sizes (20 gauges 22 gauge and 25 gauge), five needle lengths (4mm,5mm,8mm and 10mm),five working length(1200mm,1600mm, 1950mm,2000mm, 2300mm). There are 5 series (SN18-05 series, SN18-07 series, SN18-09 series, SN19-05 series and SN19-07 series) total ninety (90) specification injection needles. The Endoscopic Injection Needle is sterile, single-use device. It is expected to be used in conjunction with an endoscope to perform endoscopic injections into tissue in the GI tract during an endoscopic procedure. The Endoscopic Injection Needle is designed to pass through the endoscope's forceps to mark the lesions of the digestive tract and use it for injection. Compatibility with endoscopes, working lengths are 1600mm, 1950mm,2000mm, 2300mm, and the minimum working clamp channel is φ 2.8 mm.