FDA Product Code
FDA Product Code QQH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.4450
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252339 | iotaSOFT® Insertion System | Iotamotion, Inc. | 2026-01-09 | Traditional | PDF ↗ |
| DEN190055 | iotaSOFT Insertion System - Drive Unit, Controller and Accessories | Iotamotion, Inc. | 2021-10-01 | Direct | — |
Product code QQH · Class II · Ear, Nose, Throat. Data: openFDA.