ETA
- Product code
- ETA
- Device name
- Replacement, Ossicular Prosthesis, Total
- Device class
- Class 2
- 21 CFR
- 21 CFR 874.3495
- Medical specialty
- Ear, Nose, Throat
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 39 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260719 | 2026-04-03 | MED-EL Elektromedizinische Geräte GmbH | mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Tota… | |
| K241269 | 2025-01-17 | MED-EL Elektromedizinische Geräte GmbH | mXACT Total Prosthesis Offcenter, mXACT Total Prosth… |
Official FDA classification page: ETA
Classification and pathway per current FDA publications. Data from openFDA (CC0).