De Novo
DEN220052: BrachyGel Vaginal Hydrogel Packing System
FDA De Novo · brachyfoam, inc. d/b/a advaray · decided Aug 22, 2023
Key facts
| De Novo number | DEN220052 |
|---|---|
| Device name | BrachyGel Vaginal Hydrogel Packing System |
| Applicant | brachyfoam, inc. d/b/a advaray |
| Product code | QXR |
| Date received | Aug 25, 2022 |
| Decision date | Aug 22, 2023 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Radiology |
| FEI number | 3017608802 |
At a glance
- None Later 510(k)s citing this De Novo
- 1–9 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: