Clearance Summary
MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 3 received FDA 510(k) clearance under submission number K051613, 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 2005-08-15.
- Submission: K051613
- 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: 2005-08-15
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.