Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments
FDA 510(k) clearance K190589 · decided 2019-07-03
Clearance details
- K-number
- K190589
- Device name
- Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments
- Applicant
- Cochlear Americas
- Decision
- Substantially Equivalent
- Date received
- 2019-03-07
- Decision date
- 2019-07-03
- Days to decision
- 118 days
- Clearance type
- Traditional
- Product code
- PFO
- Device class
- 2
- Regulation number
- 874.3340
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Centennial, CO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S240) | Cochlear Americas | 2025-12-19 |
| Nucleus® Hybrid L24 Cochlear Implant System (P130016/S058) | Cochlear Americas | 2025-10-16 |
| Nucleus® 24 Cochlear Implant System (P970051/S236) | Cochlear Americas | 2025-10-16 |
| Nucleus® 24 Cochlear Implant System (P970051/S238) | Cochlear Americas | 2025-09-26 |
| Cochlear Nucleus® System (P970051/S237) | Cochlear Americas | 2025-09-02 |
| Nucleus® 24 Cochlear Implant System (P970051/S235) | Cochlear Americas | 2025-08-06 |
| Nucleus® 24 Cochlear Implant System (P970051/S234) | Cochlear Americas | 2025-07-24 |
| Nucleus® 22 Cochlear Implant System (P890027/S064) | Cochlear Americas | 2025-07-03 |