Clearance Summary
SELFX XPERT BILIARY STENT, MODELS EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006, EX8L4006, EX8S2005, AND EX8S3005 received FDA 510(k) clearance under submission number K033537, sponsored by Abbott Laboratories. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2003-12-10.
- Submission: K033537
- Applicant / Sponsor: Abbott Laboratories
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5010
- Decision date: 2003-12-10
Classification & Regulation
This clearance is catalogued under FDA product code FGE and 21 CFR 876.5010, within the Gastroenterology, Urology review panel as a Class II device.