De Novo
DEN150033: Sensor Monitored Alimentary Restriction Therapy (SMART) Device
FDA De Novo · scientific intake · decided Sep 26, 2016
Key facts
| De Novo number | DEN150033 |
|---|---|
| Device name | Sensor Monitored Alimentary Restriction Therapy (SMART) Device |
| Applicant | scientific intake |
| Product code | ONY |
| Date received | Jul 31, 2015 |
| Decision date | Sep 26, 2016 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Gastroenterology & Urology |
| FEI number | 3004501997 |
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: