De Novo
DEN150038: CleanCisionTM Wound Retraction and Protection System
FDA De Novo · prescient surgical · decided Dec 16, 2016
Key facts
| De Novo number | DEN150038 |
|---|---|
| Device name | CleanCisionTM Wound Retraction and Protection System |
| Applicant | prescient surgical |
| Product code | PQI |
| Date received | Aug 13, 2015 |
| Decision date | Dec 16, 2016 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | General & Plastic Surgery |
| FEI number | 3014131608 |
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: