510(k) K260719
mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50 by
MED-EL Elektromedizinische Geräte GmbH
— Product Code ETA
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
- Replacement, Ossicular Prosthesis, Total
- Device Class
- Class II
- Regulation Number
- 874.3495
- Review Panel
- EN
- Submission Type