Clearance Summary
OMNILINK .035 BILIARY STENT SYSTEM received FDA 510(k) clearance under submission number K053459, sponsored by Guidant Corporation. 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 2006-04-12.
- Submission: K053459
- Applicant / Sponsor: Guidant Corporation
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5010
- Decision date: 2006-04-12
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.