Clearance Summary
IONOS(R) OSSICLE 5MM & 7MM received FDA 510(k) clearance under submission number K911583, sponsored by Ionos GmbH & Co. KG. 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 1991-09-09.
- Submission: K911583
- Applicant / Sponsor: Ionos GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3495
- Decision date: 1991-09-09
Classification & Regulation
This clearance is catalogued under FDA product code ETA and 21 CFR 874.3495, within the Ear, Nose, Throat review panel as a Class II device.