Clearance Summary
LIFESTENT FLEXSTART BILIARY STENT SYSTEM received FDA 510(k) clearance under submission number K053404, sponsored by Edwards Lifesciences, LLC. 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 2005-12-21.
- Submission: K053404
- Applicant / Sponsor: Edwards Lifesciences, LLC
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5010
- Decision date: 2005-12-21
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.