# K252648: Niti-S SPAXUS Stent

- Pathway: 510(k) (Traditional)
- Applicant: Taewoong Medical Co., Ltd.
- Decided: Mar 13, 2026 after 204 days
- Product code: PCU (Pancreatic Stent, Covered, Metallic, Removable)
- Device class: 2
- Regulation: 21 CFR 876.5015
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K970053 (1997). 17 ancestors in all.
No later device cites it as a predicate yet.
1 of 18 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233318: AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm), Boston Scientific Corporation (2023) Summary page 5.
- K203132: AXIOS Stent and Electrocautery Enhanced Delivery System, Boston Scientific Corporation (2021) Summary page 7.
- K220112: AXIOS Stent and Electrocautery-Enhanced Delivery System, Boston Scientific Corporation (2022) Summary page 7.
- DEN230019: AXIOS Stent and Electrocautery-Enhanced Delivery System  (10mm x 10mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System  (15mm x 10mm Stent), Boston Scientific Corporation (2023) Summary page 8.

## Indications for use
8mmx20mm stents: The Niti-S SPAXUST™ Stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts >6 cm in size, that are adherent to the gastric or bowel wall and are free of solid debris. The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst resolution. 10mmx20mm and 16mmx20mm stents: The Niti-S SPAXUST™ 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.

Source page: https://510kreport.com/device/K252648
Methodology: https://510kreport.com/methodology