510(k) K260718
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) by
MED-EL Elektromedizinische Geräte GmbH
— Product Code ETB
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 3, 2026
- Date Received
- March 5, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Partial Ossicular Replacement
- Device Class
- Class II
- Regulation Number
- 874.3450
- Review Panel
- EN
- Submission Type