Clearance Summary
EVOLUTION BILIARY STENT SYSTEM received FDA 510(k) clearance under submission number K121430, sponsored by Cook Ireland, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2013-03-01.
- Submission: K121430
- Applicant / Sponsor: Cook Ireland, Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5010
- Decision date: 2013-03-01
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.