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This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of - 1. Endoscopic marking, - 2. Hemostasis for - · Mucosal/submucosal defects less than 3 cm - · Bleeding ulcers, - · Arteries less than 2 mm, - · Polyps less than 1.5 cm in diameter, - · Diverticula in the colon, and - · 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 for closure of GI tract luminal perforations less than 20mm that can be treated conservatively 5. Anchoring to affix fully covered esophageal self-expanding metal stents to the wall of the esophagus in patients with fistulas, leaks, perforations, or disunion.

The Instinct Plus Endoscopic Clipping Device is a sterile, single use metallic clip used for tissue approximation and hemostasis in the gastrointestinal tract. The metallic clip is 14.4 mm long and has an opening span of 16 mm. The clip is preloaded on a 230 cm long introducer comprised of a coated coil spring, drive wire and deployment handle. The clip may be deployed to the site of interest using a straight viewing flexible endoscope with a minimum accessory channel of 2.8 mm, or side viewing flexible endoscope with a minimum accessory channel of 4.2 mm. The clip can be rotated for positioning by rotating the handle of the introducer and may be reopened and closed up to five times prior to deployment. The Instinct Plus Endoscopic Clipping Device is supplied sterilized by ethylene oxide gas in a peel-open package and intended for one-time use. The product is packaged with one-year shelf life.

This device is used for endoscopic injection into gastrointestinal mucosa. The intended population is adult use only.

The Gastrointestinal Injection Needles (subject devices) are sterile, single use devices that consist of a needle on an inner catheter fitted inside an outer catheter sheath featuring a luer slip/adjustment wheel handle with either a plastic or metal hub used as an injection port at the proximal end of the device. The devices are compatible with endoscopes with a minimum accessory channel of 2.0 mm or 2.8 mm. The Gastrointestinal Injection Needles have catheters which ranges in length from 195 to 315 cm, outer diameters of 5.4 FR and 6.9 FR, and needle gauges of 21, 23 and 25. Some configurations of the Gastrointestinal Injection Needles include ink marks at the distal end of the device to aid endoscopic visualization.

Howell D.A.S.H.® Sphincterotome with Dome Tip® (Cook Reference Part Numbers DASH-21, DASH-21-480, DASH-1, DASH-260, DASH-480, DASH-ACRO-25-450, DASH-35, DASH-ACRO-35-260, DASH-35-480, DASHACRO-35-450): This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP. Tri-Tome pc® Triple Lumen Sphincterotome (Cook Reference Part Numbers TRI-20, TRI-20M, TRI-25, TRI-25M, TRI-25M-P, TRI-25M-SLT, TRI-30, TRI-30M): This device is used for cannulation of the ductal system and for sphincterotomy. Classic Cotton® CannulaTome® (Cook Reference Part Numbers CCPT-25, CCPT-25-MONO, CCPT-25ME), CannulaTome II® Double Lumen Sphincterotome (Cook Reference Part Numbers CT-20, CT-20M, CT-30, CT-30M), Cotton Cannulatome II PreCurved Double Lumen Sphincterotome (Cook Reference Part Numbers CT-25, CT-25M, CT-25M-P UTS®), and Ultra Taper Sphincterotome (Cook Reference Part Numbers UTS-15, UTS-20, UTS-20M, UTS-25, UTS-25M, UTS-30, UTS-30M): This device is used for cannulation of the ductal system and for sphincterotomy. Billroth II Sphincterotome (Cook Reference Part Numbers PTG-20-6-BII-NG) and Soehendra® BII Sphincterotome (Cook Reference Part Numbers PT-5.5-BII-SOEHENDRA): This device is used for the cannulation of the ductal system and for sphincterotomy. Models ACU-1 and ACU-1-VL active cords: This device is used to connect Cook monopolar electrosurgical accessories to compatible electrosurgical generators.

The sphincterotomes described in this submission are a sterile, single use devices compatible with the accessory channel of endoscope. The device consists of a long, thin plastic tube (cannula) 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 highfrequency current through the wire, exposing the biliary or pancreatic orifices for selective cannulation. The active cords are accessories to sphincterotomes so that a sphincterotome can be connected to an electrosurgical unit.

This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP.

The Fusion® OMNI Sphincterotome (subject device) is a sterile, single use device compatible with the accessory channel of endoscope. The device consists of a long, thin plastic tube (cannula) 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.

These devices are used for accessing the duct when standard methods of cannulation have been exhausted.

The Zimmon Needle Knife Papillotome (subject device) is a sterile, single use device compatible with the accessory channel of endoscope. The device consists of a long, thin plastic tube (cannula) 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 highfrequency current through the needle knife, exposing the biliary or pancreatic orifices for selective cannulation.

This device is used to collect cells from the bronchi or upper and lower gastrointestinal tracts.

The Bronchi and Gastrointestinal Cytology Brush (subject device) is a sterile, single use device compatible with the accessory channel of endoscopes. The device consists of stainless steel coil spring terminating in a nylon brush at the distal end. The coil spring and brush are secured inside an extruded polytetrafluoroethylene sheath. The brush is advanced from and retracted into the sheath.

This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of endoscopic marking, hemostasis for mucosal/submucosal defects less than 3 cm in the upper GI tract, bleeding ulcers, arteries less than 2 mm, and polyps less than 1.5 cm in diameter in the GI tract. This device is not intended for the repair of GI tract lumenal perforations.

The Disposable Hemostasis Clip is a sterile, single use device that consists of a metal clip that detaches from the introducer to maintain approximation of tissue to achieve hemostasis in the gastrointestinal tract. The device is compatible with endoscopes with a minimum accessory channel of 2.8 mm. The Disposable Hemostasis Clip is 230 cm long. The deployed clip portion of the Disposable Hemostasis Clip is stainless steel and nitinol while the introducer is nylon, stainless steel and nitinol.

Intended to implant fiducials under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures.

The EchoTip® Ultra Fiducial Needle is composed of a delivery system (i.e., needle, sheath, handle, and stylet) with four pure gold fiducials preloaded and secured within a laser-cut track in the needle. The needle is dimpled to enhance its echogenicity, allowing the user to target tissues using endoscopic ultrasound guidance. The needle stylet is advanced to deploy the fiducials. Once deployed, the fiducials are permanent implants that serve as radiopaque reference points for future therapeutic procedures.

Used to dilate strictures of the gastrointestinal tract, including strictures of the esophagus, pylorus, duodenum and colon.

The modified Hercules 3 Stage Wire Guided Balloon consists of coaxial catheter with a dilation balloon mounted on the distal tip. The balloon is inflatable with fluid to three distinct and progressively larger size diameters to exert pressure on strictures and affect dilation of the stricture. It is offered in a variety of balloon diameters. Supplied sterile and Intended for Single Use. Inflation device sold separately.

This device is intended to be used with an ultrasound endoscope for delivery of injectable materials into tissues during endoscopic procedures and fine needle aspirations (FNA) of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the GI tract.

The Endoscopic Ultrasound Needle is offered in various needle gauges for injection or aspiration. This device is used in conjunction with an ultrasound endoscope to gain access to the target site. The needle which is dimpled for ultrasonic visualization is advanced into the target site for injection of therapeutic materials or aspiration. The device allows for adjustment of the length of the sheath and needle to enable the user to adjust for the working length of the endoscope and to control needle insertion depth. It is preloaded with a stylet to aid in inserting the needle which is removed for injection and aspiration. The device is supplied sterile and intended for single use only.