De Novo
DEN180013: PREVENA 125 and PREVENA PLUS 125 Therapy Units
FDA De Novo · kci usa, inc. · decided Apr 19, 2019
Key facts
| De Novo number | DEN180013 |
|---|---|
| Device name | PREVENA 125 and PREVENA PLUS 125 Therapy Units |
| Applicant | kci usa, inc. |
| Product code | QFC |
| Date received | Mar 15, 2018 |
| Decision date | Apr 19, 2019 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | General & Plastic Surgery |
| FEI number | 3005178245 |
At a glance
- 1–9 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: