Clearance Summary
VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE VA2, VISERA CYSTO-NE received FDA 510(k) clearance under submission number K133538, sponsored by Olympus Corporation 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 2014-08-07.
- Submission: K133538
- Applicant / Sponsor: Olympus Corporation of the Americas
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2014-08-07
Classification & Regulation
This clearance is catalogued under FDA product code NWB and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.