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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.

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 used for endoscopic removal of biliary stones and for contrast injection.

The subject extraction balloon is comprised of a latex balloon mounted at the distal end of a nylon catheter with three internal lumens. The balloon can be inflated to three diameter sizes, 8.5 mm, 12 mm and 15 mm. Radiopaque bands placed at the distal and proximal ends of the balloon provide fluoroscopic visualization of the balloon location. The catheter length is 275 cm with a diameter of 6.6 Fr. The three lumens correspond to a balloon inflation port, a wire guide port and an injection port. The hubs on the respective lumens are color-coded white, purple, and gray. A stopcock is included at the proximal end of the balloon inflation port to control air movement into or out of the balloon.

This device is used for endoscopic cannulation of the ductal system. This device is indicated for adult use only.

The subject devices consist of a catheter with a T-fitting, a Y-body connector, a hub, or a female luer lock on the proximal handle and 3 MM markings at the distal radiopaque tip. The device distal tip configurations include stainless steel metal, tapered, dome and/or angled tips. ERCP catheters are available in single, double, or triple lumen configurations. All devices have an injection port/wire guide port. Some catheters include a stylet wire to facilitate advancement of the catheter, which is removed prior to wire guide insertion or contrast injection. ERCP catheters are used by passing the device through an endoscope. The injection port/wire guide port is then used to allow fluoroscopic visualization by injecting contrast and/or wire guide access to the desired duct.

This device is used in obtaining biopsy samples in the bronchi or lungs. This device is indicated for adult use only.

The Captura® Disposable Bronchoscope Biopsy Forceps (subject device) represents modifications made to the Disposable Bronchoscope Biopsy Forceps (predicate device) currently cleared to market via 510K K923847 by Wilson-Cook Medical, Inc. The Captura® Disposable Bronchoscope Biopsy Forceps consist of a spool handle, coated coilspring catheter, drive cable, forceps cups and forceps housing. The bronchoscope biopsy forceps is used by passing the device through a prepositioned endoscope to the targeted location. The forceps cups are attached on one end of the coilspring sheath with the spool handle attached to the opposite end. The handle is actuated by moving the spool forward to open the forceps cups and backward to close. The Captura® Bronchoscope Biopsy Forceps have a surgical rim edge around the circumference of the cups and the cups are fenestrated. The cups are opened and pressed against the biopsy site. When the cups are closed, they are pulled away from the biopsy site, pinching off the top surface, obtaining a tissue biopsy.

This device is used to sample targeted submucosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope. The target population is adult use only.

The ECHO-3-22: Echotip Ultra and the EUSN-1, EUSN-3: Echotip Ultrasound Needles are sterile, single use devices. The Ultrasound Needles consist of an adjustable luer slip handle, an outer and an inner catheter with a needle, extension locks (ECHO-3-22) or spacers (EUSN-1, EUSN-3), a stylet, and a syringe with a stopcock. All devices are compatible with ultrasound endoscopes with a minimum accessory channel of 2.8 mm. The catheter is made of polyether ether ketone, PEEK (ECHO-3-22), or polytetrafluoroethylene, PTFE (EUSN-1, EUSN-3), while the needle of all devices is stainless steel, and the stylet is nitinol. The tips of the needles are dimpled for echogenicity.

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

The modified EchoTip® Ultra Fiducial Needle is generally identical to the cleared predicate device. The modified device is also 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. The Intended Use and Indications for Use are identical in the modified device as is the fundamental operating principle. Modifications to this iteration of the device include minor dimensional, geometric and tolerance adjustments.

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 Instinct Endoscopic Hemoclip is a sterile, single use device that consists of 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 Instinct Endoscopic Hemoclip is 230 cm long. The deployed clip portion of the Instinct Endoscopic Hemoclip is stainless steel and nitinol while the introducer is nylon, stainless steel and nitinol.

This device is intended to assist in cannulation of the biliary and pancreatic ducts and to aid in bridging difficult strictures during ERCP

The proposed Endoscopic Wire Guide is a modification to existing wire guides currently marketed by Wilson-Cook Medical, Inc. The Endoscopic Wire Guide is .025" in diameter and is compatible with a full range of Wilson-Cook accessories.

This device is indicated for submucosal lift of polyps or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device.

The proposed Cook Device is assembled by the end user from three component pieces: a handle with a threaded piston and directional arrow, a sterile needle cannula with an attached pressure gauge to track pressure in the event of needle kinks/bends in the tortuous GI anatomy and a sterile 10 cc syringe filled with a mixture of sterile water and sodium CMC. Blue colorant may or may not be added to enhance endoscopic visibility. After creation of a starter bleb below affected tissue, the gel is then injected into the starter bleb. The bleb will then stay elevated from the muscle layer to allow for endoscopic dissection or resection with a separately supplied endoscopic electrosurgical device. After excision and retrieval of affected tissue, the bleb will dissolve and pass out of the body naturally.