Clearance Summary
ULTRA Telescopes received FDA 510(k) clearance under submission number K153009, sponsored by Olympus Winter & Ibe GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2016-04-05.
- Submission: K153009
- Applicant / Sponsor: Olympus Winter & Ibe GmbH
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4760
- Decision date: 2016-04-05
Classification & Regulation
This clearance is catalogued under FDA product code EOB and 21 CFR 874.4760, within the Ear, Nose, Throat review panel as a Class II device.