QQH — Powered Insertion System For A Cochlear Implant Electrode Array Class II
FDA product code QQH covers "Powered Insertion System For A Cochlear Implant Electrode Array", a Class II medical device regulated under 21 CFR 874.4450. Submissions are reviewed by the Ear, Nose, Throat panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QQH
- Device Class
- Class II
- Regulation Number
- 874.4450
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- 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.