De Novo
DEN090011: HEM-AVERT PERIANAL STABILIZER
FDA De Novo · plexus biomedical inc. · decided Jan 13, 2011
Key facts
| De Novo number | DEN090011 |
|---|---|
| Device name | HEM-AVERT PERIANAL STABILIZER |
| Applicant | plexus biomedical inc. |
| Product code | OOA |
| Date received | Aug 18, 2009 |
| Decision date | Jan 13, 2011 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Obstetrics/Gynecology |
| FEI number | 1000058335 |
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: