K241142 is an FDA 510(k) clearance for the mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis. This device is classified as a Prosthesis, Partial Ossicular Replacement (Class II - Special Controls, product code ETB).
Submitted by Med-El Elektromedizinische Ger?te GmbH (Innsbruck, AT). The FDA issued a Cleared decision on January 17, 2025, 267 days after receiving the submission on April 25, 2024.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3450.
| 510(k) Number | K241142 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 25, 2024 |
| Decision Date | January 17, 2025 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | ETB - Prosthesis, Partial Ossicular Replacement |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3450 |