Clearance Summary
SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE received FDA 510(k) clearance under submission number K080050, sponsored by Spirus Medical, 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 2008-05-06.
- Submission: K080050
- Applicant / Sponsor: Spirus Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2008-05-06
Classification & Regulation
This clearance is catalogued under FDA product code FED and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.