De Novo
DEN190022: Hominis Surgical System
FDA De Novo · memic innovative surgery ltd. · decided Feb 26, 2021
Key facts
| De Novo number | DEN190022 |
|---|---|
| Device name | Hominis Surgical System |
| Applicant | memic innovative surgery ltd. |
| Product code | QNM |
| Date received | Apr 17, 2019 |
| Decision date | Feb 26, 2021 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | General & Plastic Surgery |
| FEI number | 3014155960 |
At a glance
- 1–9 Later 510(k)s citing this De Novo
- None 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: