Clearance Summary
mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850) received FDA 510(k) clearance under submission number K260718, sponsored by MED-EL Elektromedizinische Geräte GmbH. The device was reviewed via the Special premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2026-04-03.
- Submission: K260718
- Applicant / Sponsor: MED-EL Elektromedizinische Geräte GmbH
- Clearance pathway: Special
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3450
- Decision date: 2026-04-03
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.