De Novo
DEN100026: APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE
FDA De Novo · aptus endosystems, inc. · decided Nov 21, 2011
Key facts
| De Novo number | DEN100026 |
|---|---|
| Device name | APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE |
| Applicant | aptus endosystems, inc. |
| Product code | OTD |
| Date received | Dec 14, 2010 |
| Decision date | Nov 21, 2011 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Cardiovascular |
At a glance
- 1–9 Later 510(k)s citing this De Novo
- None UDI device identifiers (GUDID)
- 10–99 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: