510(k) K252339
- Device
- iotaSOFT® Insertion System
- Applicant
- Iotamotion, Inc.
- 510(k) number
- K252339
- Product code
- QQH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-01-09
- Date received
- 2025-07-28
- Regulation
- 874.4450
- Classification name
- Powered Insertion System For A Cochlear Implant Electrode Array
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Khamporn Pendergrass
- Address
- 4205 White Bear Pkwy. Suite 600 St. Paul MN US 55110 55110
FDA Registration Numbers#
- 3023531666
- 2030624
- 3030411493
- 3031976597
Source Documents#
Other 510(k) Records For Product Code QQH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN190055 | iotaSOFT Insertion System - Drive Unit, Controller and Accessories | Iotamotion, Inc. | 2021-10-01 |