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Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/ Stent Sets (GEPD, GPDS, GPSO, GPSOS); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF); Endoscopic pancreatic stent placement is used for pancreatic drainage that could be caused by pancreatitis, stricture, pancreatic cancer, anatomic anomalies of the pancreas, pancreatic fluid collection, pancreatic stones, disrupted duct, fistula/pancreatic leak. Pancreatic stents are also used prophylactically for prevention of post-ERCP pancreatitis. Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS): Endoscopic pancreatic stent placement for pancreatic drainage of obstructed ducts that could be caused by pancreatitis, stricture, pancreatic cancer, anatomic anomalies of the pancreas, pancreatic fluid collection, pancreatic stones, and disrupted duct. Pushing Catheter and Guiding Catheter (GC, PC): These devices are indicated for use with biliary and pancreatic stents for the following indications. For endoscopic biliary stent placement for biliary drainage of obstructed ducts that could be caused by common bile duct stones, malignant biliary obstruction and benign or malignant strictures. For endoscopic pancreatic stent placement for pancreatic duct drainage that could be caused by pancreatitis, stricture, pancreatic cancer, anatomic anomalies of the pancreatic fluid collection, pancreatic stones, disrupted duct, fistula / pancreatic leak. Pancreatic stents are also used prophylactically for prevention of post-ERCP pancreatitis.

The intended use of all Cook pancreatic stents and sets is to drain pancreatic ducts. A variety of stents in different sizes are available across the device range to accommodate various patient anatomies, the size and location of the obstruction and physician preference. They are offered in French sizes of between 3Fr and 11.5Fr, and in labelled lengths of between 2cm and 25cm.The subject devices and their components can be supplied as stent only, introducer only (guiding or pushing catheter) or as stent sets combining stent and introducers/introducer systems. The stent sets can contain one or several of the following stent placement components; a flap protector, a guiding catheter, a pushing catheter or a dedicated introducer system. The flap protector is provided with stents that have duodenal flap-type anti-migration features, and is used to collapse the flap(s) on the device as it is introduced into the working channel of the endoscope. The function of the guiding catheter is to guide the pancreatic stent as part of its introduction to its intended location. The guiding catheter also has a Hub that allows for contrast injection. The function of the Pushing Catheter is to advance the stent, over a pre-positioned wire guide or Guiding Catheter, to its intended location within the anatomy, and to maintain the position of the Stent as it being deployed. The stents are polymeric and some of the stents have radiopaque bands. The stent designs include anti-migrational features such as duodenal pigtails, duodenal bends and ductal and duodenal flaps. To facilitate stent insertion and removal the stent ends are tapered or buffed. Side-ports on the pancreatic stents assist in drainage. All stents are deployed endoscopically over a guide wire in the same manner under fluoroscopic and endoscopic monitoring. These Cook pancreatic stents and sets are all for professional use and are provided sterile. They are all intended for short-term use and have an indicated indwell of up to 3 months.

This device is used with an ultrasound endoscope for fine needle biopsy (FNB), of submucosal and extramural lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the GI tract.

The EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) is an endoscopic ultrasound needle consisting of a needle assembly and syringe. The needle assembly is comprised of a handle, sheath, stylet and needle cannula. This device is available in one 22Ga needle size.

Endoscopic biliary stent placement for biliary drainage of obstructed ducts that could be caused by common bile duct stones, malignant biliary obstruction, benign or malignant strictures or other obstructed biliary conditions requiring drainage.

The Compass BDS® Biliary Stent includes double pigtails with double radiopaque marker bands. Compass BDS® Biliary Stents are recommended for use with Cook stent introducers (PC-7, PC-7E, and FS-PC-7). The product code for Compass BDS® Biliary Stent is CBBSO-X-Y (CBBSO-7-5, CBBSO-7-10, CBBSO-7-15), where X denotes French size (Fr) and Y denotes the length in centimeters (cm). This product contains a stent and a pigtail straightener. The stent design allows the stent to be introduced on either side and the double-pigtails minimize migration, while side holes enhance biliary fluid drainage. It also has a tapered tip at both ends to facilitate smooth cannulation. The stent has two radiopaque bands on both ends for fluoroscopic visibility.

The EchoTip® Ultra Endoscopic Ultrasound Needle is used with an ultrasound endoscope for fine needle aspiration (FNA) of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract. The EchoTip ProCore® HD Ultrasound Biopsy Needle is used with an ultrasound endoscope for fine needle biopsy (FNB), of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract. Echotip® Ultra Endobronchial High Definition Ultrasound Needle for Olympus scopes: This device is used to sample targeted submucosal and extramural lesions within or adjacent to the tracheobronchial tree or gastrointestinal tract through the accessory channel of an ultrasound endoscope for Fine Needle Aspiration (FNA). Echotip® Ultra Endobronchial High Definition Ultrasound Needle for Pentax scopes: This device is used to sample targeted submucosal and extramural lesions within or adjacent to the tracheobronchial tree through the accessory channel of an ultrasound endoscope for Fine Needle Aspiration (FNA). Echotip Procore® Endobronchial High Definition Ultrasound Biopsy Needle for Olympus scopes: This device is used with an ultrasound endoscope for fine needle biopsy, (FNB), of submucosal and extramural lesions within or adjacent to the tracheobronchial tree or gastrointestinal tract. Echotip Procore® Endobronchial High Definition Ultrasound Biopsy Needle for Pentax scopes: This device is used with an ultrasound endoscope for fine needle biopsy, (FNB), of submucosal and extramural lesions within or adjacent to the tracheobronchial tree.

EchoTip Ultra Endoscopic Ultrasound Needle: This Needle is used in conjunction with an ultrasound endoscope and is available in needle gauge sizes of 19, 22 and 25 Ga. The device comprises of a needle assembly and a syringe. The needle assembly consists of the needle cannula, stylet, sheath and handle. The stainless steel needle cannula has a dimpling pattern on the distal end to allow visualization of the needle tip under endoscopic ultrasound. The purpose of the needle cannula is for puncturing of the target site. The preloaded nitinol stylet is withdrawn from the needle when obtaining sample from the target site. The sheath covers the needle when it is not in use. The device handle allows for needle and sheath length adjustment. The syringe can aid in sample aspiration. The device is supplied sterile and is intended for single use. The device is for Rx use only. EchoTip ProCore HD Ultrasound Biopsy Needle: This Needle is used in conjunction with an ultrasound endoscope and is available in needle gauge sizes of 19, 20, 22 and 25 ga. The device comprises of a needle assembly and a syringe. The needle assembly consists of the needle cannula, stylet, sheath and handle. The stainless steel needle cannula has a dimpling pattern on the distal end to allow visualization of the needle tip under endoscopic ultrasound. The needle cannula has a bevelled tip design and a notch. The purpose of the needle cannula is for puncturing/biopsy of the target site. The preloaded nitinol stylet is withdrawn from the needle for biopsy. Some variants have a stylet that coils when not in the needle. The sheath covers the needle when it is not in use. The device handle allows for needle and sheath length adjustment. The syringe can aid in tissue aspiration. The device is supplied sterile and is intended for single use. The device is for Rx use only. EchoTip Ultra / ProCore Endobronchial High Definition Ultrasound Needle: These Needles are used in conjunction with an endobronchial ultrasound endoscope and is available with needle gauge sizes of 22 and 25 Ga. The device is composed of a needle assembly and a syringe. An adapter can also be supplied for use with endobronchial ultrasound endoscopes with metal non-Luer hubs. The needle assembly consists of the needle cannula, stylet, sheath and handle. The stainless steel needle cannula has a dimpling pattern on the distal end to allow visualization of the needle tip under endoscopic ultrasound. The needle cannula has a bevelled tip design and comes either with or without a notch. The purpose of the needle cannula is for puncturing/sampling of the target site. The needle is provided with a preloaded stylet which remains in place during advancement of the needle. The sheath covers the needle when the needle is retracted and not in use. The device handle allows for needle and sheath length adjustment. The stylet/syringe can aid in specimen retrieval. The device is supplied sterile and intended for single use only. The device is for Rx use only.

The EchoTip® Insight™ Portosystemic Pressure Gradient Measurement System is indicated to directly measure pressures in the hepatic and portal venous vasculatures and is used in conjunction with an ultrasound endoscope.

The EchoTip® Insight™ Portosystemic Pressure Gradient Measurement System is a system used to provide endoscopic access to the portal and hepatic veins to measure local blood pressure. As shown in Figure 1, the system is composed of: 1. EchoTip Insight Endoscopic Ultrasound Needle 2. Connecting Tube 3. 10 mL syringe 4. Stopcock 5. Compass CT Pressure Transducer (K133624). The EchoTip® Insight™ Needle functions to provide access to the venous vasculature related to the portal circulation and hepatic outflow to facilitate the measurement of physiological pressure by the Compass® CT pressure transducer, a disposable manometer (cleared under K133624). The needle is enclosed within a 5.2 Fr. outer sheath for protection. The sheath has an adjustable length (0-5 cm) to allow the user to adjust for the working length of the endoscope. The sheath length extension lock ring allows the sheath to be secured in place by tightening the thumbscrew. The needle extension is also adjustable and ranges from 0-8 cm. The "zero" reference ensures complete needle retraction within the sheath. The handle has a safety ring that slides and locks using the thumbscrew at the desired needle extension. The Connecting Tube is used for the transfer of liquids (heparinized saline) between the EchoTip® Insight™ Needle and the Compass® CT pressure transducer. The Connecting Tube uses a female Luer lock to connect to the Compass CT pressure transducer, and a male Luer lock to connect to the stopcock. The Compass CT is a disposable, point-of-use blood pressure measurement and monitoring device that incorporates an embedded pressure sensor and an integrated, pre-programmed diagnostic computer chip with a liquid crystal display. Once the system is connected and primed with heparinized saline, the EchoTipe Insight™ Needle is passed through the accessory channel of an ultrasound endoscope and the needle is advanced to the desired vasculature (portal or hepatic vein) through the liver parenchyma. Using ultrasound guidance, the needle is placed at the desired location, allowed to stabilize, and a measurement reading is taken.

The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.

The Zilver® 518 and 635TM Biliary Stent is a self-expandable stent made of nitinol. The special laser-cut pattern of the nitinol tube provides a construction with strong radial force and high flexibility. It is a slotted tube that is designed to provide support while maintaining flexibility in the duct upon deployment. Post-deployment, the stent is designed to impart an outward radial force upon the inner lumen of the duct, establishing patency in the stented region, thereby maintaining constant flow in the duct. The stent has radiopaque markers (gold rivets) at both ends to assist in fluoroscopic visualization of the stent position. The delivery system for both ZIB5 and ZIB6 devices includes a handle assembly and an introducer catheter assembly. The Zilver® 518 and 635™ Biliary Stent is mounted on the inner catheter of the delivery system and is restrained by an outer sheath. The delivery system is used to deliver the stent to the appropriate location. The stent is deployed by retracting the outer sheath while holding the central metal cannula stationary. Full deployment of the stent occurs when the distal end of the sheath has been retracted past the proximal end of the stent is placed using fluoroscopic and percutaneous techniques.

Stents: Zimmon® Pancreatic Stent/Stent Sets, Geenen® Pancreatic Stent/Stent Sets and Johlin® Pancreatic Wedge Stent and Introducer. This device is used to drain obstructed pancreatic ducts. Stent Introducers: Guiding Catheter and Pushing Catheter. This device is used for endoscopic pancreatic stent placement.

The intended use of all Cook pancreatic stents is to drain obstructed pancreatic ducts. A variety of stents in different sizes are available across the device range to accommodate various patient anatomies, the size and location of the obstruction and physician preference. They are offered in French sizes of between 3Fr and 11.5Fr, and in labelled lengths of between 2cm and 25cm.The subject devices and their components can be supplied as stent only, introducer only (guiding or pushing catheter) or as stent sets combining stent and introducers/introducer systems. The stent sets can contain one or several of the following stent placement components; a flap protector, a guiding catheter, a pushing catheter or a dedicated introducer system. The flap protector is provided with stents that have duodenal flap-type anti-migration features, and is used to collapse the flap(s) on the device as it is introduced into the working channel of the endoscope. The function of the guiding catheter is to guide the pancreatic stent as part of its introduction to its intended location. The guiding catheter also has a Hub that allows for contrast injection. The function of the Pushing Catheter is to advance the stent, over a prepositioned wire guide or Guiding Catheter, to its intended location within the anatomy, and to maintain the position of the Stent as it being deployed. The stents are polymeric and some of the stents have radiopaque bands. The stent designs include anti-migrational features such as duodenal pigtails, duodenal bends and ductal and duodenal flaps. To facilitate stent insertion and removal the stent ends are tapered or buffed. Side-ports on the pancreatic stents assist in drainage. All stents are deployed endoscopically over a guide wire in the same manner under fluoroscopic and endoscopic monitoring. These Cook pancreatic stents are all for professional use and are provided sterile. They are all intended for short-term use and have an indicated indwell of up to 3 months.

These devices are used to drain obstructed biliary ducts. The following devices are used for endoscopic biliary stent placement: Guiding Catheter Pushing Catheter Fusion® Pushing catheter Stent Introducer Set The following devices (with preloaded stent, if applicable) are intended for endoscopic biliary stent placement to drain obstructed bile ducts: Oasis® One Action Stent Introduction System Fusion® Oasis® One Action Stent Introduction System Oasis® One Action Stent Introduction System with preloaded Cotton-Leung® Biliary Stent. Oasis® One Action Stent Introduction System with preloaded ST-2 Tannenbaum® Biliary Stent.

The intended use of all Cook biliary stents is to drain obstructed biliary ducts. A variety of stents in different sizes are available across the device range to accommodate various patient anatomies, the size and location of the obstruction and physician preference. They are offered in French sizes of between 5Fr and 11.5Fr, and in labelled lengths of between 1cm and 21cm.The subject devices and their components can be supplied as stent only, introducer only (guiding or pushing catheter), introduction system (guiding and pushing catheter) or as stent sets combining stent and introducers/introduction systems. The stent sets can contain one or several of the following stent placement components; a flap protector/ pigtail straightener, a guiding catheter, a pushing catheter or a dedicated introducer system. The flap protector/ pigtail straightener can be provided to aid in introduction of the device over the wire (pigtail stents) and introduced into the working channel of the endoscope. The function of the guiding catheter is to guide the stent as part of its introduction to its intended location. The guiding catheter also has a Hub that allows for contrast injection. The function of the Pushing Catheter is to advance the stent, over a pre-positioned wire guide or Guiding Catheter, to its intended location within the anatomy, and to maintain the position of the Stent as it being deployed. Some introducers / introduction systems have a port that will allow use of the device in a short wire configuration. The stents are polymeric with some of the stents have radiopaque bands. The stent designs include centre, duodenal and centre bend shapes and anti-migration features such as pigtails and flaps. To facilitate stent insertion and removal the stent ends are tapered or buffed. Side-ports on the stents assist in drainage. All stents are deployed endoscopically over a guide wire in the same manner under fluoroscopic and endoscopic monitoring.

This device is used for treatment of acute non-toxic megacolon, (Ogilvie's syndrome) and colonic strictures.

The CDSG device consists of a colon decompression tube, guiding catheter and wire guide. The colon decompression tube is 14Fr in diameter with a length of 175cm. The device design includes side ports which allow for colon decompression. The device has connections to allow attachment to drainage collection bag or for the device to be flushed. The colon decompression tube, guiding catheter and wire guide can be observed fluoroscopically. The device is supplied sterile, intended for single use only. Use of this device is restricted to a trained healthcare professional. The CDSM device consists of a colon decompression tube and wire guide. The colon decompression tube is supplied in a range of diameter options, 7Fr. 8.5Fr and 10Fr. The colon decompression tube has a length of 350cm. The device design includes side ports which allow for colon decompression. The device has connections to allow attachment to drainage collection bag or for the device to be flushed. The colon decompression tube and wireguide can be observed fluoroscopically. The colon decompression tube has a design feature (pigtail) at the distal end of the device which helps reduce migration. The device is supplied sterile, intended for single use only. Use of this device is restricted to a trained healthcare professional. The same wire guide is supplied with both the CDSG and CDSM devices; the wire guide has a flexible distal ball tip.