mGRIP Total Prosthesis (3.00 mm) (58689) +11 more— 510(k) K260719
Substantially EquivalentMED-EL Elektromedizinische Geräte GmbH
FDA 510(k) clearance K260719 for mGRIP Total Prosthesis (3.00 mm) (58689) +11 more, Substantially Equivalent on 2026-04-03. Applicant: MED-EL Elektromedizinische Geräte GmbH. Device class: 2.
Summary
MED-EL Elektromedizinische Geräte's record lists mGRIP Total Prosthesis entries from 3.00 mm to 6.00 mm, each with its own number, and the device name is cut off partway through a 6.50 mm entry. All are filed under product code ETA (Replacement, Ossicular Prosthesis, Total).
Class II, 21 CFR 874.3495. It came in as a Special 510(k), and Ear, Nose, and Throat is both the classification panel and the review panel.
MED-EL filed from Innsbruck, Austria. Review took 29 calendar days (March 5 to April 3, 2026).
Clearance details
- Device name as filed
- 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
- Product code
- Product code ETA
- Device class
- Class 2
- Regulation
- 21 CFR 874.3495
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Innsbruck, AT
Recent devices under product code ETA
view all- K260264 — Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON)
- K241269 — mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit
- K091187 — GRACE DYNAMIC TORP
- K083780 — SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2
- K043375 — FISCH TITANIUM MIDDLE EAR PROSTHESES
More clearances from MED-EL Elektromedizinische Geräte GmbH
view all- K260718 — mGRIP Partial Prosthesis (0.75 mm) (58669) +10 more
- K260720 — mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717) +9 more
- K241142 — mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis
- K241261 — mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit
Data sourced from openFDA. This site is unofficial and independent of the FDA.