Niti-S SPAXUS Stent
FDA 510(k) K252648 · Taewoong Medical Co., Ltd.
510(k) numberK252648
Submission
- Device name
- Niti-S SPAXUS Stent
- Applicant
- Taewoong Medical Co., Ltd.
Gyeonggi-Do, KR - Received
- August 21, 2025
- Decision date
- March 13, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PCU – Pancreatic Stent, Covered, Metallic, Removable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5015
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
To facilitate transmural endoscopic drainage of pancreatic pseudocysts
Other 510(k)s with product code PCU
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220112 | AXIOS Stent and Electrocautery-Enhanced Delivery SystemPCU · Traditional | Boston Scientific Corporation | 09/07/2022SE |
| K203132 | AXIOS Stent and Electrocautery Enhanced Delivery SystemPCU · Traditional | Boston Scientific Corporation | 04/15/2021SE |
| K192043 | AXIOS Stent and Electrocautery Enhanced Delivery SystemPCU · Traditional | Boston Scientific Corporation | 08/26/2019SE |
| K181905 | AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery SystemPCU · Traditional | Boston Scientific Corporation | 03/25/2019SE |
| K163272 | AXIOS Stent and Electrocautery Enhanced Delivery SystemPCU · Traditional | Boston Scientific Corporation | 02/18/2017SE |
| K153088 | AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery…PCU · Traditional | Boston Scientific Corporation | 12/11/2015SE |
| K152572 | AXIOS Stent and Delivery SystemPCU · Special | Boston Scientific Corporation | 10/06/2015SE |
| K150692 | AXIOS Stent with Electrocautery Enhanced Delivery SystemPCU · Traditional | Boston Scientific Corp | 08/05/2015SE |
| K140561 | Axios Stent and Delivery System (with 10MM X 10MM Stent) Axios Stent and Delivery System…PCU · Special | Xlumena, Inc. | 04/23/2014SE |
More from Xlumena, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260962 | SphincterotomeKNS · Traditional | 05/21/2026SE |
| K251123 | Niti-S Biliary Stent; Niti-S Biliary Slim M StentFGE · Traditional | 12/29/2025SESU |
| K243619 | Niti-S Esophageal Stent; Esophageal TTS StentESW · Traditional | 10/30/2025SE |
| K250663 | Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort StentMUM · Special | 03/31/2025SE |
| K240522 | Esophageal TTS StentESW · Special | 03/22/2024SE |
| K223067 | Niti-S Duodenal Stent; Niti-S Colonic Comfort StentMUM · Traditional | 06/14/2023SE |
| K223626 | Niti-S Biliary Speed D StentFGE · Traditional | 05/26/2023SESU |
| K223256 | Optimos CystotomeKNS · Traditional | 04/05/2023SE |
| K221482 | Esophageal TTS StentESW · Special | 06/22/2022SE |
| K221071 | Niti-S Biliary Slim M StentFGE · Traditional | 06/09/2022SESU |
Questions and answers
When was Niti-S SPAXUS Stent cleared by the FDA?
Niti-S SPAXUS Stent (K252648) received a 510(k) decision of Substantially Equivalent on March 13, 2026, 204 days after the submission was received.
What is the product code of K252648?
The FDA product code is PCU – Pancreatic Stent, Covered, Metallic, Removable, a Class II (moderate risk) device regulated under 21 CFR 876.5015.