FDA Product Code
FDA Product Code QML — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4835
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| DEN240007 | BioHealx Anal Fistula Device | Signum Surgical Limited | 2024-07-01 | Direct | — |
Product code QML · Class II · General, Plastic Surgery. Data: openFDA.