K182116 is an FDA 510(k) clearance for the BA310 Abutment, BIA310 Implant/Abutment. This device is classified as a Hearing Aid, Bone Conduction, Implanted (Class II - Special Controls, product code MAH).
Submitted by Cochlear Americas (Centennial, US). The FDA issued a Cleared decision on December 19, 2018, 135 days after receiving the submission on August 6, 2018.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3302.
| 510(k) Number | K182116 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 06, 2018 |
| Decision Date | December 19, 2018 |
| Days to Decision | 135 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | MAH — Hearing Aid, Bone Conduction, Implanted |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3302 |