Clearance Summary
EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V received FDA 510(k) clearance under submission number K143153, 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 2016-01-15.
- Submission: K143153
- 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: 2016-01-15
Classification & Regulation
This clearance is catalogued under FDA product code FDT and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.