K241261 is an FDA 510(k) clearance for the mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit. 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, 266 days after receiving the submission on April 26, 2024.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3450.
| 510(k) Number | K241261 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 2024 |
| Decision Date | January 17, 2025 |
| Days to Decision | 266 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 |