510(k) K260719 · ETA Replacement, Ossicular Prosthesis, Total
mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP
| 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 K260719
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.