Axios Stent and Delivery System (with 10MM X 10MM Stent) Axios Stent and Delivery System (with 15MM X 10MM Stent)
FDA 510(k) K140561 · Xlumena, Inc.
510(k) numberK140561
Submission
- Device name
- Axios Stent and Delivery System (with 10MM X 10MM Stent) Axios Stent and Delivery System (with 15MM X 10MM Stent)
- Applicant
- Xlumena, Inc.
Mountain View, CA, US - Received
- March 5, 2014
- Decision date
- April 23, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|---|
| K252648 | Niti-S SPAXUS StentPCU · Traditional | Taewoong Medical Co., Ltd. | 03/13/2026SE |
| 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 |
More from Boston Scientific Corp
| 510(k) | Device | Decision |
|---|---|---|
| K093279 | Navix Access DeviceGCJ · Traditional | 04/07/2010SE |
Questions and answers
When was Axios Stent and Delivery System (with 10MM X 10MM Stent) Axios Stent and Delivery System (with 15MM X 10MM Stent) cleared by the FDA?
Axios Stent and Delivery System (with 10MM X 10MM Stent) Axios Stent and Delivery System (with 15MM X 10MM Stent) (K140561) received a 510(k) decision of Substantially Equivalent on April 23, 2014, 49 days after the submission was received.
What is the product code of K140561?
The FDA product code is PCU – Pancreatic Stent, Covered, Metallic, Removable, a Class II (moderate risk) device regulated under 21 CFR 876.5015.