Clearance Summary
ENDOSCOPY VIDEO CAMERA SYSTEM received FDA 510(k) clearance under submission number K081585, sponsored by Vision Systems Group, A Division of Viking Systems. 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 2008-06-20.
- Submission: K081585
- Applicant / Sponsor: Vision Systems Group, A Division of Viking Systems
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2008-06-20
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.