DEN240007
- 510(k) number
- DEN240007
- Device name
- BioHealx Anal Fistula Device
- Applicant
- Signum Surgical Limited IE
- Product code
- QML — Anal Fistula Closure Device
- Decision date
- 2024-07-01
- Date received
- 2024-02-02
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- General, Plastic Surgery
Official FDA record: DEN240007
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.