De Novo
DEN120023: GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM
FDA De Novo · given imaging ltd. · decided Jan 29, 2014
Key facts
| De Novo number | DEN120023 |
|---|---|
| Device name | GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM |
| Applicant | given imaging ltd. |
| Product code | PGD |
| Date received | Nov 29, 2012 |
| Decision date | Jan 29, 2014 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Gastroenterology & Urology |
| FEI number | 3003348376 |
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: