Product code
QQH: Powered insertion system for a cochlear implant electrode array
FDA product code · Class II · Ear Nose & Throat
Key facts
| Product code | QQH |
|---|---|
| Device | Powered insertion system for a cochlear implant electrode array |
| Device class | Class II |
| Regulation number | 874.4450 |
| Review panel | Ear Nose & Throat |
| Medical specialty | Ear Nose & Throat |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| 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. |
At a glance
- 1–9 510(k) clearances
- 1–9 De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- 10–99 MAUDE adverse event reports
- 1–9 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database