510(k) K260720 · ETB Prosthesis, Partial Ossicular Replacement
mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING
| Applicant | MED-EL Elektromedizinische Geräte GmbH, Innsbruck, AT |
| Decision | Substantially Equivalent, Apr 3, 2026 |
| Received | Mar 5, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K260720
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.