# QQH: Powered Insertion System For A Cochlear Implant Electrode Array

- Device class: 2; regulation: 21 CFR 874.4450; FDA's rule: 510(k) required
- FDA decisions: 2
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2021: 1
- 2026: 1

## Most-cited predicates
- DEN190055: iotaSOFT Insertion System - Drive Unit, Controller and Accessories (2021), cited by 1

Source page: https://510kreport.com/product-code/QQH
Data by year (CSV): https://510kreport.com/product-code/QQH.csv