Clearance Summary
HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L received FDA 510(k) clearance under submission number K090980, sponsored by Olympus Winter & Ibe GmbH. 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 2009-06-29.
- Submission: K090980
- Applicant / Sponsor: Olympus Winter & Ibe GmbH
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2009-06-29
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.