DEN190055 is an FDA 510(k) submission for the iotaSOFT Insertion System - Drive Unit, Controller and Accessories. This device is classified as a Powered Insertion System For A Cochlear Implant Electrode Array (Class II - Special Controls, product code QQH).
Submitted by Iotamotion, Inc. (Iowa City, US). The FDA issued a Not Cleared (DENG) decision on October 1, 2021.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4450. 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..
| 510(k) Number | DEN190055 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | December 18, 2019 |
| Decision Date | October 01, 2021 |
| Days to Decision | 653 days |
| Submission Type | Direct |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | - |
| Product Code | QQH - Powered Insertion System For A Cochlear Implant Electrode Array |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.4450 |
| 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. |