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This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, the device also aids in bridging difficult strictures during ERCP. Also indicated for sphincterotome-aided, wire-quided selective cannulation of the biliary ducts. Tesla BiCord Active Cord: This device is used to connect the Teslatome Bipolar Sphincterotome to compatible electrosurgical generators.

ln a sphincterotomy, access to the biliary tract is gained by passing a sphincterotome through a duodenoscope and positioning the distal tip adjacent to the major papilla is cannulated using the tip of the sphincterotome. The papilla is then incised using an electrosurgical current applied to the cutting wire by an electrosurgical generator that is connected to the sphincterotome by an active cord. The Teslatome consists of a three-ring handle, tri-lumen catheter, and cutting wire with a connection to an electrosurgical generator via the Tesla BiCord active cord. The connection delivers a current to the cutting wire that is exposed at the device. A multilumen catheter allows for the injection of contrast and/or the passage over a prepositioned wire guide using the proximal end of the device.

The Micropuncture® Introducer Set is intended for the placement of wire guides up to 0.038-inch diameter into the peripheral vascular system when a small 21 gage needle stick is desired. The Micropuncture® Pedal Access Set is intended to introduce up to an 0.038" wire guide into the peripheral vasculature. It is also used to introduce diagnostic and/or interventional devices able to pass through the ID of the introducer.

The Micropuncture® Introducer Sets and Micropuncture® Pedal Access Sets are utilized to gain access to the vasculature using the Seldinger technique. These introducer sets are composed of either a 4.0 French or a 5.0 French outer sheath and a 3.0 French inner dilator coaxial pair, a 21 gage percutaneous entry needle, a 0.018 inch mandrel with a distal coil tip, and (optionally) a Check-Flo® Hemostasis valve, a Tuohy-Borst Sidearm Adapter, and a wire guide inserter. The dilator of these sets can come with a stainless steel stiffening cannula embedded in the shaft. These sets are supplied sterile and are intended for one-time use.

This device is an accessory to be used with endoscopic biliary and pancreatic devices to lock the wire guide(s) in place and to prevent reflux of bodily fluids during ERCP

The SnapLoc Wire Lock device is an accessory that is clipped onto the outside of a Duodenoscope during Endoscopic Retrograde Cholangio-Pancreatography (ERCP) procedures. Its purpose is to help control the wire guides during a procedure, to enable ERCP devices (catheters, baskets, balloons, stents, etc) to pass through the device and to prevent the backflow of bodily fluids during procedures. The SnapLoc wire lock contains features to aid in wire control. The wire is locked into place by simply sliding the wire into one of the locking notches located on the left and right sides of the wire is unlocked by lifting the wire out of the wire locking notch. For control, the proximal end of the wire can be secured by inserting it into one of the docking channels. A silicone seal located between the molded components helps reduce leakage from the duodenoscope. For ease of connection, the wire lock attaches to the duodenoscope by sliding laterally onto the port until secure. The SnapLoc will be sold in three sizes to be compatible with the most commonly used endoscopes from Olympus. Fuji, and Pentax.

The Entuit PEG is intended for percutaneous endoscopic gastrostomy placement to provide enteral nutrition and/or medication to patients requiring nutritional support, and gastric decompression. This device is indicated for adult use only. The Entuit PEGJ is intended for percutaneous endoscopic placement to provide enteral nutrition and/or medication to patients requiring nutritional support, and gastric decompression. This device is indicated for adult use only.

The Entuit PEG (subject device) includes a silicone enteral feeding tube (PEG tube) available in 24 Fr or 20 Fr, with site preparation components, introduction components, adapters, and connectors. The device is supplied sterile and is intended for single use in adults. Entuit PEGJ (subject device) includes a polyurethane enteral feeding tube (PEGJ tube) that is available in 12 Fr or 9 Fr. The Entuit PEGJ tube is for direct access to the jejunum. The 12 Fr PEGJ tube is designed to be inserted through the 24 Fr PEG tube and the 9 Fr PEGJ tube is designed to be inserted through the 20 Fr PEG tube such that the distal end extends into the jejunum and the proximal end extends out of the existing PEG tube. There are several feeding adapters for use with the PEG and PEGJ tubes. The PEG kit has one feeding adapter that is ENFit compatible and two feeding adapters that are compatible with Christmas tree/slip tip giving sets and syringes (Non-ENFit). The PEGJ tubes are also available with either ENFit compatible or Christmas tree compatible feeding adapters (Non-ENFit). The Entuit PEG is provided as a kit to facilitate either push or pull techniques of placement. In addition, the Entuit PEG kits are available in standard, safety, and international versions. The Entuit PEGJ is sold as a separate kit and available in standard versions.

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 20 mm 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 three-year shelf life.

This device is intended to provide short-term enteral access for delivery of nutrition and/or medications to small bowel. This device is indicated for adult use only.

The subject device is packaged with: a nasal feeding tube, a nasal transfer tube, a wire guide, and two feeding adapters. The single lumen nasal feeding tube is composed of radiopaque polyvinyl chloride with ink markings that are endoscopically visible and assist with tube placement. The nasal feeding tube is available in two diameters, 8 Fr and 10 Fr. with a length of 240 cm and 10 feeding ports. The nasal transfer tube has a diameter of 14 Fr, is composed of clear PVC and is 20 inches in length. The wire guide is stainless steel coated with polytetrafluoroethylene (PTFE) and is 250 cm in length. Two feeding adapters are provided; one as a friction fit version and one ENFit compatible.

The COOK Hemospray device is intended for hemostasis of non-variceal bleeds in the GI (gastrointestinal) tract. It is for prescription use only.

Hemospray is an inert, bentonite powder developed for endoscopic hemostasis. The powder is delivered by use of a carbon dioxide powered delivery system and through a catheter inserted through the working channel of an endoscope which provides access to the bleed. Each device contains approximately 20g of powder.

This device is used for endoscopic removal of stones in the biliary system and for contrast injection.

The subject device is composed of a latex balloon mounted at the distal end of a nylon triple lumen catheter. The balloon can be inflated to four sizes: 8.5 mm, 10 mm, and 15 mm diameters. Radiopaque bands are placed on the catheter to provide fluoroscopic visualization of the catheter and balloon location. The nylon catheter length is 200 cm with a diameter of 6.6 Fr. There is an injection port on the catheter either above the balloon or below the balloon depending on the device model. The catheter also has black ink markings for direct visualization.

The TeslaTome Bipolar Sphincterotome is intended for cannulation of the ductal system and sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP (endoscopic retrograde cholangiopancreatography). Also indicated for sphincterotome-aided, wire-guided selective cannulation of the biliary ducts. The Tesla Bipolar Active Cord is used to connect the TeslaTome to compatible electrosurgical generators.

The TeslaTome Bipolar Sphincterotome is an endoscopic electrosurgical accessory composed of a single stainless steel drive wire within a triple-lumen polymer catheter. The proximal end of the catheter/wire assembly terminates in a handle, held by the physician or assistant during ERCP procedures and fulfills three (3) functions: connection to an electrosurgical generator, injection of diluted contrast, introduction of an endoscopic wire guide and manipulation of the cutting wire. The distal end contains a stainless steel cutting wire and ink and band markings. Half of the cutting wire is insulated with a non-conductive polymer coating. The device allows for short-wire, distal wire guide exchange through the separation of a weakened wall in the wire guide lumen that separates with manual control. The device is also compatible with traditional long wire guides. The TeslaTome Bipolar Sphincterotome is available in eight model numbers reflecting cutting wire length of 20 or 25 mm, and a .035" Acrobat II wire guide in either 260 cm or 450 cm length, and an optional rotatable handle. The Tesla Bipolar Active Cord (TESLA-ACU-B) is used to facilitate connection to an Electrosurgical generator (ESU). It uses a magnetic connection at the sphincterotome alignment but facilitates connection with ERBE generators on the distal end with conventional ESU-compatible plugs. The Active cord is non-sterile and reusable.

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.