De Novo
DEN110016: PERCUTANEOUS SURGICAL SET WITH 5MM OR 10MM ATTACHMENTS
FDA De Novo · ethicon endo-surgery · decided Apr 30, 2012
Key facts
| De Novo number | DEN110016 |
|---|---|
| Device name | PERCUTANEOUS SURGICAL SET WITH 5MM OR 10MM ATTACHMENTS |
| Applicant | ethicon endo-surgery |
| Product code | OXT |
| Date received | Sep 21, 2011 |
| Decision date | Apr 30, 2012 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | General & Plastic Surgery |
| FEI number | 1527736 |
At a glance
- None 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: