De Novo
DEN250068: OTTAVA™ Robotic Surgical System
FDA De Novo · auris health, inc., part of johnson & johnson medtech · decided Jul 21, 2026
Key facts
| De Novo number | DEN250068 |
|---|---|
| Device name | OTTAVA™ Robotic Surgical System |
| Applicant | auris health, inc., part of johnson & johnson medtech |
| Product code | SIR |
| Date received | Dec 18, 2025 |
| Decision date | Jul 21, 2026 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | General & Plastic Surgery |
| FEI number | 3017425975 |
At a glance
- None Later 510(k)s citing this De Novo
- None UDI device identifiers (GUDID)
- None 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: