De Novo
DEN240007: BioHealx Anal Fistula Device
FDA De Novo · signum surgical limited · decided Jul 1, 2024
Key facts
| De Novo number | DEN240007 |
|---|---|
| Device name | BioHealx Anal Fistula Device |
| Applicant | signum surgical limited |
| Product code | QML |
| Date received | Feb 2, 2024 |
| Decision date | Jul 1, 2024 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | General & Plastic Surgery |
| FEI number | 3015615781 |
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: