K252339
- 510(k) number
- K252339
- Device name
- iotaSOFT® Insertion System
- Applicant
- Iotamotion, Inc. MN · US
- Product code
- QQH — Powered Insertion System For A Cochlear Implant Elec
- Decision date
- 2026-01-09
- Date received
- 2025-07-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K252339.pdf
Official FDA record: K252339
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.