Clearance Summary
ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8 received FDA 510(k) clearance under submission number K031347, sponsored by Olympus Optical Co., Ltd.. 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 2003-05-09.
- Submission: K031347
- Applicant / Sponsor: Olympus Optical Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2003-05-09
Classification & Regulation
This clearance is catalogued under FDA product code ODG and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.