De Novo
DEN170064: Comaneci, Comaneci Petit, Comaneci 17
FDA De Novo · rapid-medical ltd. · decided Apr 24, 2019
Key facts
| De Novo number | DEN170064 |
|---|---|
| Device name | Comaneci, Comaneci Petit, Comaneci 17 |
| Applicant | rapid-medical ltd. |
| Product code | PUU |
| Date received | Sep 28, 2017 |
| Decision date | Apr 24, 2019 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Neurology |
| FEI number | 3009957947 |
At a glance
- None Later 510(k)s citing this De Novo
- 1–9 UDI device identifiers (GUDID)
- 10–99 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: