Clearance Summary
GORE VIABIL BILILARY ENDOPROSTHESIS received FDA 510(k) clearance under submission number K081184, sponsored by W.L. Gore & Associates, Inc. Medical Products Div.. 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 2008-07-22.
- Submission: K081184
- Applicant / Sponsor: W.L. Gore & Associates, Inc. Medical Products Div.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5010
- Decision date: 2008-07-22
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.