Clearance Summary
VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA received FDA 510(k) clearance under submission number K242067, sponsored by Olympus Corporations of the Americas. 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 2025-04-02.
- Submission: K242067
- Applicant / Sponsor: Olympus Corporations of the Americas
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2025-04-02
Classification & Regulation
This clearance is catalogued under FDA product code FET and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.