Cleared Special

K260719 - mGRIP Total Prosthesis (3.00 mm) (58689) (FDA 510(k) Clearance)

Also includes:
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

Class II Ear, Nose, Throat device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K260719 · Med-El Elektromedizinische Ger?te GmbH · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2026
Decision
29d
Days
Class 2
Risk

K260719 is an FDA 510(k) clearance for the mGRIP Total Prosthesis (3.00 mm) (58689). Classified as Replacement, Ossicular Prosthesis, Total (product code ETA), Class II - Special Controls.

Submitted by Med-El Elektromedizinische Ger?te GmbH (Innsbruck, AT). The FDA issued a Cleared decision on April 3, 2026 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3495 - the FDA ear, nose and throat device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Med-El Elektromedizinische Ger?te GmbH devices

Submission Details

510(k) Number K260719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2026
Decision Date April 03, 2026
Days to Decision 29 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 89d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code ETA Replacement, Ossicular Prosthesis, Total
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3495
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.