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mGRIP Total Prosthesis - mGRIP Total Prosthesis (3.00 mm) (58689)

by MED-EL Elektromedizinische Geräte GmbH

510(k) K260719

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK260719 Date3 Apr 2026ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ETA
Models / Variants
mGRIP Total Prosthesis (3.00 mm) (58689)
Device Class
Class II
Regulation
21 CFR Part 874.3495
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The mGRIP Total Prosthesis is a replacement ossicular prosthesis used in ear, nose, and throat procedures. It is designed to replace damaged or missing ossicles in the middle ear to restore sound transmission.

The device is available in multiple sizes ranging from 3.00 mm to 6.50 mm and is manufactured by MED-EL Elektromedizinische Geräte GmbH. It has received FDA 510(k) clearance with a special clearance type and is classified as a Class II medical device.

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