Niti-S SPAXUS Stent

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 23 Oct 2026.

Generic Name

Implantable transenteric drainage tube

Model / Ref / Catalog

SS1002FW, SS0802FW

Primary DI / UDI-DI

08809482273375 EUDAMED

08809482273436 EUDAMED

08809909422294 GUDID

08809909422287 GUDID

Basic UDI-DI

B-08809482273375, B-08809482273436

510(k) Number

K252648 ↗

FDA Product Code

PCU, QXH

EMDN Code

P0502 Biliary and pancreatic prostheses

GMDN Term

Implantable transenteric drainage tube

Device Class

Class IIb EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 876.5015 510(k)GUDID

876.5016 GUDID

EU market of registration

Netherlands

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

MRI Safety

MR Conditional

Size

Outer Diameter — 10 Millimeter

Length — 2 Centimeter

Outer Diameter — 8 Millimeter

• PULSTA™ Transcatheter Pulmonary Valve System

  Class III

  CE/MDR MDR 796279 Active Valid to Jan 2031

• ComVi Pyloric/Duodenal Stent [Both Bare-Type]

  Class IIb

  CE/MDD

• ComVi Enteral Colonic Stent [Both Bare-Type]

  Class IIb

  CE/MDD

• ComVi Pyloric/Duodenal Stent [Flare-Type]

  Class IIb

  CE/MDD

• Niti-S Biliary Uncovered Stent [LCD-Type]

  Class IIb

  CE/MDD

• Niti-S Biliary Covered Stent [Flare-Type]

  Class IIb

  CE/MDD

See all devices from Taewoong Medical Co., Ltd. →

• What types of fluid collections is the Niti-S SPAXUS Stent specifically designed to address during endoscopic drainage procedures?

  The Niti-S SPAXUS Stent is designed to facilitate drainage of specific fluid collections such as pseudocysts or walled-off necrosis in high-risk patients. Its lumen-apposing design ensures stable placement for targeted transgastric or transduodenal drainage, addressing these complex collections where traditional stents may fall short.

• How long can the Niti-S SPAXUS Stent remain implanted in a patient, and is it intended for reuse?

  The Niti-S SPAXUS Stent is intended for single-use implantation only, with a maximum recommended duration of up to 60 days. Its silicone-coated, metallic construction is not designed for reuse, and the manufacturer emphasizes adherence to this timeframe to ensure optimal performance and patient safety.

• What makes the silicone coating on the Niti-S SPAXUS Stent important for clinical use?

  The silicone coating on the Niti-S SPAXUS Stent serves a critical function by reducing friction and preventing migration or leakage during implantation. This design feature enhances stability and lumen apposition, which is particularly valuable in high-risk patients where maintaining proper drainage is essential for treatment success.

• How is the Niti-S SPAXUS Stent supplied, and what should clinicians consider regarding sterility?

  The Niti-S SPAXUS Stent is supplied sterile by the manufacturer, ensuring readiness for immediate use in endoscopic procedures. Clinicians should confirm the sterile packaging is intact before opening and follow standard aseptic techniques to maintain sterility throughout the implantation process, as it is intended for single-use only.

• What regulatory pathways does the Niti-S SPAXUS Stent follow, and which advisory committees were involved in its evaluation?

  The Niti-S SPAXUS Stent was cleared under the FDA 510(k) pathway and complies with the Medical Device Directive (MDD). Its evaluation involved the Gastroenterology and Urology (GU) Advisory Committee, reflecting its dual relevance to both specialties in managing pancreatic fluid collections and related complications.