Clearance Summary
VIABIL BILIARY ENDOPROSTHESIS received FDA 510(k) clearance under submission number K014215, sponsored by W. L. Gore & Associates, Inc.. 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 2002-12-19.
- Submission: K014215
- Applicant / Sponsor: W. L. Gore & Associates, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5010
- Decision date: 2002-12-19
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.