Clearance Summary
Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments received FDA 510(k) clearance under submission number K190589, sponsored by Cochlear Americas. 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 2019-07-03.
- Submission: K190589
- Applicant / Sponsor: Cochlear Americas
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3340
- Decision date: 2019-07-03
Classification & Regulation
This clearance is catalogued under FDA product code PFO and 21 CFR 874.3340, within the Ear, Nose, Throat review panel as a Class II device.