Clearance Summary
EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I received FDA 510(k) clearance under submission number K001241, sponsored by The Olympus Optical Co.. 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 2000-05-09.
- Submission: K001241
- Applicant / Sponsor: The Olympus Optical Co.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2000-05-09
Classification & Regulation
This clearance is catalogued under FDA product code FDF and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.