QQH

Powered Insertion System For A Cochlear Implant Electrode Array

Product code

QQH

Device name

Powered Insertion System For A Cochlear Implant Electrode Array

Device class

Class 2

21 CFR

21 CFR 874.4450

Medical specialty

Ear, Nose, Throat

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-01-09.

1 summaries are archived here for direct download.