DeviceClearance

Product code QQH— Ear, Nose, Throat

iotaSOFT Insertion System - Drive Unit, Controller and Accessories

Classification name
Powered Insertion System For A Cochlear Implant Electrode Array
Device class
Class 2
Regulation
21 CFR 874.4450
Advisory panel
Ear, Nose, Throat
Total cleared
2
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QQH under 21 CFR 874.4450, via openFDA

Market context for product code QQH

FDA has cleared 2 devices under product code QQH between 2021 and 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QQH

Recent clearances under product code QQH

Data sourced from openFDA. This site is unofficial and independent of the FDA.