Pancreatic Stent, Covered, Metallic, Removable
FDA product code PCU · Class II (moderate risk) · 21 CFR 876.5015 · Gastroenterology, Urology
To facilitate transmural endoscopic drainage of pancreatic pseudocysts
10510(k) clearances
0PMA approvals
6recalls
Implantimplanted device
Manufacturers
510(k) clearances
| 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 |
| K140561 | Axios Stent and Delivery System (with 10MM X 10MM Stent) Axios Stent and Delivery System…PCU · Special | Xlumena, Inc. | 04/23/2014SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0778-2021 Class II | Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN:…The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose… | Boston Scientific Corporation | 12/01/2020Terminated |
| Z-0777-2021 Class II | Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm (OUS) UPN:…The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose… | Boston Scientific Corporation | 12/01/2020Terminated |
| Z-0776-2021 Class II | Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm (OUS) UPN:…The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose… | Boston Scientific Corporation | 12/01/2020Terminated |
| Z-0775-2021 Class II | AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm UPN: M00553660 -…The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose… | Boston Scientific Corporation | 12/01/2020Terminated |
| Z-0774-2021 Class II | AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm UPN: M00553650 -…The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose… | Boston Scientific Corporation | 12/01/2020Terminated |
| Z-0773-2021 Class II | AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00553640 -…The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose… | Boston Scientific Corporation | 12/01/2020Terminated |