De Novo
DEN160040: Embosphere Microspheres
FDA De Novo · biosphere medical s.a. · decided Jun 21, 2017
Key facts
| De Novo number | DEN160040 |
|---|---|
| Device name | Embosphere Microspheres |
| Applicant | biosphere medical s.a. |
| Product code | NOY |
| Date received | Aug 5, 2016 |
| Decision date | Jun 21, 2017 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Gastroenterology & Urology |
| FEI number | 3002808761 |
At a glance
- 1–9 Later 510(k)s citing this De Novo
- 10–99 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: