mGRIP Total Prosthesis (3.00 mm) (58689) +11 more— 510(k) K260719

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

Code ETA

Device class

Class 2

Regulation

21 CFR 874.3495

Advisory panel

Ear, Nose, Throat

Date received

2026-03-05

Decision date

2026-04-03

Decision

Substantially Equivalent

Clearance type

Special

Location

Innsbruck, AT

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