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The Ultraflex Esophageal NG Stent is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only. The Ultraflex Esophageal NG Covered Stent System is also indicated for occlusion of concurrent esophageal fistula. The WallFlex Esophageal Partially Covered and Fully Covered Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.

The Ultraflex Esophageal NG Stent System allows placement of a self-expanding metallic stent within the esophagus. The systems consist of a flexible delivery system preloaded with an expandable with or without a cover. The WallFlex Esophageal Stent System consists of a self-expanding esophageal metal stent and a delivery system.

The Agile Esophageal Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.

The Agile Esophageal Stent System consists of a self-expanding esophageal metal stent and a delivery system. The Agile Esophageal Stent is available partially or fully covered with silicone covering and in three diameter sizes: 14mm, 18mm and 23mm. The 14mm and 18mm diameter stents are pre-loaded on a 10.5Fr delivery system and the 23mm diameter stent is pre-loaded on an 18.5Fr delivery system. The 10.5Fr delivery system has a single central lumen to accommodate a 0.035" (0.89 mm) guidewire. The 18.5Fr delivery system has a single central lumen to accommodate a 0.038" (0.97mm) guidewire.

The Esophageal TTS Stent is intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and occlusion of concurrent esophageal fistulas.

The Esophageal TTS Stents that are the subject of this 510(k) are identical to the devices cleared in K221482, with the exception of the modification to its introducer system. The Esophageal TTS Stents consist of an implantable metallic stent and a disposable, flexible introducer system for placement of the stent. The stent is a flexible and expandable tubular device made of Nitinol wire that is intended to be implanted to restore the structure and/or function of the esophagus. The introducer is a disposable system for delivery and deployment of the stent at the target position. Upon deployment, the stent imparts an outward radial force on the luminal surface of the esophagus to establish patency.

The HILZO Esophageal Stents are indicated for use in esophageal strictures caused by intrinsic malignant tumors.

The HILZO Esophageal Stents are partially covered and fully covered, self-expanding tubular prosthesis designed to maintain patency of esophageal strictures. The HILZO Esophageal stents are available loaded on two styles of delivery devices, Over the Wire (OTW) and Through the Scope (TTS). The OTW delivery devices are 14Fr and the TTS is 10.5Fr to enable delivery through the working channel of an endoscope. The stents are made of Nitinol wire and are designed to prevent stent migration due to peristaltic motion and tumor in-growth. The stents are available in a variety models, diameters and lengths.

The Esophageal TTS Stent is intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and occlusion of concurrent esophageal fistulas.

The Esophageal TTS Stents consists of an implantable metallic stent and a disposable, flexible introducer system for placement of the stent is a flexible and expandable tubular device made of Nitinol wire that is intended to be implanted to restore the structure and/or function of the esophagus. The introducer is a disposable system for delivery and deployment of the stent at the target position. Upon deployment, the stent imparts an outward radial force on the luminal surface of the esophagus to establish patency.

The Agile Esophageal Partially Covered OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. The Agile Esophageal Partially Covered and Fully Covered OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.

The Agile Esophageal 23mm Partially Covered and Fully Covered Over the Wire (OTW) Stent System is comprised of a metallic implantable stent pre-loaded inside of a flexible delivery system. The stent is made from braided Nitinol wires which form a self-expanding. radiopaque (RO) cylindrical mesh. The stent has flares at each end to aid in minimizing migration after the stent is placed in the esophagus. The flares are a wider diameter than the stent body. The wire ends are looped at the end of the stent. The proximal and distal stent ends each have a continuous suture threaded around their circumferences. The suture is intended to aid in removal or repositioning during the initial stent placement procedure, to be used in the event of incorrect placement. The stent is available in either partially covered or fully covered configurations. The stent is covered with a silicone polymer to restrict turnor in-growth through the wire mesh and to occlude concurrent esophageal fistulas. The proposed stent is nearly identical in design to its predicate Agile Esophageal Stent System (K180144). The main difference between the proposed and the predicate stent is the type of delivery system used with the stent. The proposed Agile Esophageal OTW Stent is intended to be used with an over-the-wire delivery svstem. whereas the predicate Agile Esophageal Stent used a through-the-scope delivery system. The over-the-wire delivery system is a co-axial tube design. The exterior tube is used to constrain the stent before deployment and to reconstrain the stent after partial deployment. The exterior tube has clear distal section so that the constrained stent is visible. A yellow transition zone on the inner tube of the delivery system is visible between the stent and the blue outer sheath. The system has RO and visual markers to aid in accurate stent placement.

The HANAROSTENT® Esophagus Asymmetric (CCC) is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistula.

This self-expanding tubular prosthesis is designed to maintain patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. It consists of a self-expandable metal stent and a delivery device. The self-expandable metal stent is made of nickel titanium alloy (Nitinol) wire with fully covered silicone membrane, and the delivery device is made of polymeric materials. The stent is loaded into the distal part of the delivery device, and expanded in the body by pulling the outer sheath of the delivery device. The HANAROSTENT® Esophagus Asymmetric (CCC) is intended for single use only.

The Esophageal TTS Stent is intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.

The Esophageal TTS Stent consists of the implantable metallic stent and introducer system. The stent is made of Nitinol wire. It is a flexible, fine mesh tubular prosthesis that has 10 radiopaque markers; 4 in each end and 2 in the center. It has a body diameter of 18, 20 and 22mm, and a total length from 60 to 150mm. The surface of the body portion of the stent is covered with silicone. The Esophageal TTS Stent is provided in two configurations, either fully covered with silicone or with both heads not covered in silicone (bare). The introducer system accepts a 0.035 in (0.89 mm) or 0.038 in (0.97 mm) guidewire. The stent introducer system is passed over the guidewire and through an endoscope into the esophagus. The stent may be positioned appropriately using the X-ray markers for guidance under fluoroscopy.

The HANAROSTENT® Esophagus (CCC) and HANAROSTENT® Esophagus (NCN) are intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.

This self-expanding tubular prosthesis is designed to maintain patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. It consists of a self-expandable metal stent and an over the wire (OTW) delivery device. The self-expandable metal stent is made of nickel titanium alloy (Nitinol) wire, radiopaque markers made of gold wire, fully or partially covered silicone membrane, and one repositioning lasso at each end of the stent made of polymeric materials. The delivery device is made of polymeric materials. The stent is loaded into the distal part of the delivery device, and expanded in the body by pulling the outer sheath of the delivery device. The HANAROSTENT® Esophagus (CCC) and the HANAROSTENT® Esophagus (NCN) are intended for single use only.