Niti-S SPAXUS Stent

Basic Information

• Brand Name: Niti-S SPAXUS Stent
• Primary DI: 08809909422294
• Version / Model: SS1002FW
• Catalog Number: SS1002FW
• Company Name: TAEWOONGMEDICAL.CO.,LTD
• Labeler DUNS: 689484322
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-23
• Public Version: 2
• Public Version Date: 2026-04-08
• Public Version Status: Update
• Public Device Record Key: 4f24c57f-7319-42ee-959a-c0cbf5f685eb

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PCU	Pancreatic Stent, Covered, Metallic, Removable	Gastroenterology, Urology	876.5015	2
QXH	Gallbladder Drainage Stent And Delivery System	Gastroenterology, Urology	876.5016	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62611	Implantable transenteric drainage tube	A non-bioabsorbable tube intended to be endoscopically implanted transmurally between the gastrointestinal (GI) tract and a pancreatic pseudocyst or the biliary tract for drainage. It is a flanged stent-like structure made of metal which is covered/lined with a synthetic polymer material (e.g., silicone). It is typically expanded in situ (e.g., with a balloon catheter or self-expands) and disposable devices to assist implantation, with or without electrosurgical functionality, may be included with the device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08809909422294	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K252648	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	10	Millimeter
Length	2	Centimeter