Clearance Summary
AXIOS STENT AND DELIVERY SYSTEM received FDA 510(k) clearance under submission number DEN130007, sponsored by Xlumena, Inc.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2013-12-18.
- Submission: DEN130007
- Applicant / Sponsor: Xlumena, Inc.
- Clearance pathway: Post-NSE
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5015
- Decision date: 2013-12-18
Classification & Regulation
This clearance is catalogued under FDA product code PCU and 21 CFR 876.5015, within the Gastroenterology, Urology review panel as a Class II device.