Clearance Summary
AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mm x 10mm Stent) received FDA 510(k) clearance under submission number DEN230019, sponsored by Boston Scientific Corporation. The device was reviewed via the Direct premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2023-08-18.
- Submission: DEN230019
- Applicant / Sponsor: Boston Scientific Corporation
- Clearance pathway: Direct
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5016
- Decision date: 2023-08-18
Classification & Regulation
This clearance is catalogued under FDA product code QXH and 21 CFR 876.5016, within the Gastroenterology, Urology review panel as a Class II device.