Clearance Summary
Visera Elite II Video System Center, Visera Elite II Endoeye 3D received FDA 510(k) clearance under submission number K193026, sponsored by Olympus Medical Systems Corp.. 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 2020-04-03.
- Submission: K193026
- Applicant / Sponsor: Olympus Medical Systems Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2020-04-03
Classification & Regulation
This clearance is catalogued under FDA product code GCJ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.