Niti-S SPAXUS Stent SS0802FW

GUDID 08809909422287

The Niti-S SPAXUS Stent is a fully covered, self-expanding metallic stent designed for the indications listed below. The Niti-S SPAXUS Stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts >= 6 cm in size and walled-off necrosis >= 6 cm in size that are adherent to the gastric or bowel wall. Once placed, the Niti-S SPAXUS Stent functions as an access port allowing passage of standard and therapeutic endoscopes to facilitate debridement, irrigation and cystoscopy. The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution. The Niti-S SPAXUS Stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of the gallbladder in patients with acute cholecystitis who are at high risk for surgery. The Niti-S SPAXUS Stent is a fully covered, self-expanding metallic stent. The stent is constructed from nickel-titanium alloy (nitinol), which provides flexibility, durability, and self-expansion properties. Its bi-flange design ensures stable lumen apposition and minimizes the risk of migration. A complete silicone coating prevents leakage during drainage and facilitates the safe removal of the device. Radiopaque markers made of platinum/iridium and stainless steel enhance visibility under fluoroscopic guidance, aiding precise placement and monitoring. The device is provided sterile to the end user and has a 2-year shelf-life

TAEWOONGMEDICAL.CO.,LTD

Implantable transenteric drainage tube

• Primary Device ID: 08809909422287
• NIH Device Record Key: 991af4d6-118d-40be-8eab-d2bce8ebb88e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Niti-S SPAXUS Stent
• Version Model Number: SS0802FW
• Catalog Number: SS0802FW
• Company DUNS: 689484322
• Company Name: TAEWOONGMEDICAL.CO.,LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com

Device Dimensions

• Outer Diameter: 8 Millimeter
• Length: 2 Centimeter
• Outer Diameter: 8 Millimeter
• Length: 2 Centimeter
• Outer Diameter: 8 Millimeter
• Length: 2 Centimeter
• Outer Diameter: 8 Millimeter
• Length: 2 Centimeter
• Outer Diameter: 8 Millimeter
• Length: 2 Centimeter
• Outer Diameter: 8 Millimeter
• Length: 2 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809909422287 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K252648

FDA Product Code

• PCU: Pancreatic Stent, Covered, Metallic, Removable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-31
• Device Publish Date: 2026-03-23

On-Brand Devices [Niti-S SPAXUS Stent]

• 08809909422300: The Niti-S SPAXUS Stent is a fully covered, self-expanding metallic stent designed for the indic
• 08809909422294: The Niti-S SPAXUS Stent is a fully covered, self-expanding metallic stent designed for the indic
• 08809909422287: The Niti-S SPAXUS Stent is a fully covered, self-expanding metallic stent designed for the indic