Clearance Summary
mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis received FDA 510(k) clearance under submission number K241142, sponsored by MED-EL Elektromedizinische Geräte GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2025-01-17.
- Submission: K241142
- Applicant / Sponsor: MED-EL Elektromedizinische Geräte GmbH
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3450
- Decision date: 2025-01-17
Classification & Regulation
This clearance is catalogued under FDA product code ETB and 21 CFR 874.3450, within the Ear, Nose, Throat review panel as a Class II device.