Clearance Summary
SYSTEMS INTEGRATION MODEL: ENDOALPHA received FDA 510(k) clearance under submission number K100345, sponsored by Olympus Medical Systems Corporation. 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 2010-03-22.
- Submission: K100345
- Applicant / Sponsor: Olympus Medical Systems Corporation
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2010-03-22
Classification & Regulation
This clearance is catalogued under FDA product code ODA and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.