De Novo
DEN190055: iotaSOFT Insertion System - Drive Unit, Controller and Accessories
FDA De Novo · iotamotion, inc. · decided Oct 1, 2021
Key facts
| De Novo number | DEN190055 |
|---|---|
| Device name | iotaSOFT Insertion System - Drive Unit, Controller and Accessories |
| Applicant | iotamotion, inc. |
| Product code | QQH |
| Date received | Dec 18, 2019 |
| Decision date | Oct 1, 2021 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Ear, Nose, & Throat |
| FEI number | 3030411493 |
At a glance
- 1–9 Later 510(k)s citing this De Novo
- 1–9 UDI device identifiers (GUDID)
- 1–9 MAUDE adverse event reports
- None Recall events
- No Decision summary on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About De Novo classification requests
The De Novo pathway classifies novel low- to moderate-risk devices that have no legally marketed predicate; each granted request creates a new classification regulation and product code.
Source: U.S. Food and Drug Administration (FDA), De Novo database · Source date: