510(k) K260719
- Device
- 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
- Applicant
- MED-EL Elektromedizinische Geräte GmbH
- 510(k) number
- K260719
- Product code
- ETA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-04-03
- Date received
- 2026-03-05
- Regulation
- 874.3495
- Classification name
- Replacement, Ossicular Prosthesis, Total
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Vladislav Morozov
- Address
- Fürstenweg 77a Innsbruck AT 6020 6020
FDA Registration Numbers#
- 3002858762
- 3017636737
- 8010617
- 8044131
- 3001239363
- 1057421
- 3003790304
- 3009217531
- 1037007
- 9616949
- 3008812251
- 3010707607
- 1052728
- 3011050570
- 3005984081
- 3008132398
- 3006849754
- 9610617
- 3010202439
- 9612501
- 3018094310
- 2020550
- 3014342096
- 1048735
- 9710014
- 1045254
- 1928237
Source Documents#
Other 510(k) Records For Product Code ETA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241269 | mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit | MED-EL Elektromedizinische Geräte GmbH | 2025-01-17 |
| K091187 | GRACE DYNAMIC TORP | Grace Medical, Inc. | 2009-09-14 |
| K083780 | SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2 | Audio Technologies S.R.L. | 2009-03-23 |
| K043375 | FISCH TITANIUM MIDDLE EAR PROSTHESES | Karl Storz Endoscopy | 2005-01-24 |
| K042503 | KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM | Heinz Kurz GmbH Medizintechnik | 2004-10-01 |
| K030492 | TITANIUM OSSICULAR REPLACMENT SYSTEM | Invotec International, Inc. | 2003-03-03 |
| K002378 | MODULAR PORP AND TORP MODEL TBD | Gyrus Ent LLC | 2000-08-29 |
| K001406 | HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES | Mednet Locator, Inc. | 2000-08-08 |
| K001404 | GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON | Mednet Locator, Inc. | 2000-08-08 |
| K001902 | BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD | Gyrus Ent LLC | 2000-07-10 |
| K993583 | ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM | Stryker Corp. | 1999-11-10 |
| K992138 | MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES | Micromedics, Inc. | 1999-08-09 |
| K990601 | BOJRAB MICRO-TORP, MODEL 7014-5845 | Gyrus Ent LLC | 1999-03-31 |
| K981088 | MILLS COLUMELLA PROSTHESIS | Exmoor Plastics , Ltd. | 1998-06-05 |
| K972735 | TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP) | Mednet Locator, Inc. | 1997-09-05 |