De Novo
DEN130046: REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE
FDA De Novo · somna therapeutics, llc · decided Mar 6, 2015
Key facts
| De Novo number | DEN130046 |
|---|---|
| Device name | REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE |
| Applicant | somna therapeutics, llc |
| Product code | PKA |
| Date received | Nov 14, 2013 |
| Decision date | Mar 6, 2015 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Ear, Nose, & Throat |
| FEI number | 3011656501 |
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: