AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System
FDA 510(k) K181905 · Boston Scientific Corporation
510(k) numberK181905
Submission
- Device name
- AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System
- Applicant
- Boston Scientific Corporation
Marlboro, MA, US - Received
- July 16, 2018
- Decision date
- March 25, 2019
- 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 |
|---|---|---|---|
| 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 |
| 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 |
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Questions and answers
When was AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System cleared by the FDA?
AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System (K181905) received a 510(k) decision of Substantially Equivalent on March 25, 2019, 252 days after the submission was received.
What is the product code of K181905?
The FDA product code is PCU – Pancreatic Stent, Covered, Metallic, Removable, a Class II (moderate risk) device regulated under 21 CFR 876.5015.