QQH
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Powered Insertion System For A Cochlear Implant Electrode Array
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4450
- Medical specialty
- Ear, Nose, Throat
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| iotaSOFT® Insertion System (K252339) | Iotamotion, Inc. | 2026-01-09 |
| iotaSOFT Insertion System - Drive Unit, Controller and Accessories (DEN190055) | Iotamotion, Inc. | 2021-10-01 |
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