ETB
- Product code
- ETB
- Device name
- Prosthesis, Partial Ossicular Replacement
- Device class
- Class 2
- 21 CFR
- 21 CFR 874.3450
- Medical specialty
- Ear, Nose, Throat
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 4
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 74 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260720 | 2026-04-03 | MED-EL Elektromedizinische Geräte GmbH | mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWI… | |
| K260718 | 2026-04-03 | MED-EL Elektromedizinische Geräte GmbH | mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Par… | |
| K241142 | 2025-01-17 | MED-EL Elektromedizinische Geräte GmbH | mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZ… | |
| K241261 | 2025-01-17 | MED-EL Elektromedizinische Geräte GmbH | mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthes… |
Official FDA classification page: ETB
Classification and pathway per current FDA publications. Data from openFDA (CC0).