QQH · Class II · 21 CFR 874.4450

FDA Product Code QQH: Powered Insertion System For A Cochlear Implant Electrode Array

A Powered Insertion System For A Cochlear Implant Electrode Array Is A Prescription Device Used To Assist In Placing An Electrode Array Into The Cochlea.

Leading manufacturers include Iotamotion, Inc..

1
Total
1
Cleared
165d
Avg days
2026
Since

FDA 510(k) Cleared Powered Insertion System For A Cochlear Implant Electrode Array Devices (Product Code QQH)

1 devices
1–1 of 1
Cleared Jan 09, 2026
iotaSOFT® Insertion System
K252339
Iotamotion, Inc.
Ear, Nose, Throat · 165d

How to use this database

This page lists all FDA 510(k) submissions for Powered Insertion System For A Cochlear Implant Electrode Array devices (product code QQH). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Ear, Nose, Throat FDA review panel. Browse all Ear, Nose, Throat devices →