510(k) K252339 · QQH Powered Insertion System For A Cochlear Implant Electrode Array
iotaSOFT® Insertion System
| Applicant | Iotamotion, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Jan 9, 2026 |
| Received | Jul 28, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252339
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.