Clearance Summary
NIROYAL BILIARY PREMOUNTED STENT SYSTEM received FDA 510(k) clearance under submission number K012216, sponsored by Boston Scientific Scimed, Inc.. 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 2001-08-17.
- Submission: K012216
- Applicant / Sponsor: Boston Scientific Scimed, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5010
- Decision date: 2001-08-17
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.