BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇹 Austria

    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

    K Number: K260719 · Decision Apr 3, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    38
    Applicant Total
    6
    Review Days
    29

    Basic Information

    Device Name
    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
    K Number
    K260719
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    874.3495
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MED-EL Elektromedizinische Geräte GmbH
    Date Received
    March 5, 2026
    Decision Date
    April 3, 2026
    Product Code
    ETA
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ETA Replacement, Ossicular Prosthesis, Total

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (ETA), ordered by most recent decision date.

    mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    GRACE DYNAMIC TORP

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    FISCH TITANIUM MIDDLE EAR PROSTHESES

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    TITANIUM OSSICULAR REPLACMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat
    View all

    Other Clearances by MED-EL Elektromedizinische Geräte GmbH

    K Number Device Name
    K260720 mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735);
    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)
    K241261 mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit
    K241269 mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit
    K241142 mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis