K252339 is an FDA 510(k) clearance for the iotaSOFT® Insertion System. 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. (St. Paul, US). The FDA issued a Cleared decision on January 9, 2026, 165 days after receiving the submission on July 28, 2025.
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 | K252339 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 28, 2025 |
| Decision Date | January 09, 2026 |
| Days to Decision | 165 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| 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. |