De Novo
DEN220082: Breast Implant Removal Device (BIRD)
FDA De Novo · gaylord solutions, llc · decided Apr 20, 2023
Key facts
| De Novo number | DEN220082 |
|---|---|
| Device name | Breast Implant Removal Device (BIRD) |
| Applicant | gaylord solutions, llc |
| Product code | QVS |
| Date received | Nov 21, 2022 |
| Decision date | Apr 20, 2023 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | General & Plastic Surgery |
At a glance
- 1–9 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: