BioHealx Anal Fistula Device— 510(k) DEN240007
UnknownSignum Surgical Limited
FDA 510(k) clearance DEN240007 for BioHealx Anal Fistula Device, Unknown on 2024-07-01. Applicant: Signum Surgical Limited. Device class: 2.
Clearance details
- Applicant
- Signum Surgical Limited
- Product code
- Code QML
- Device class
- Class 2
- Regulation
- 21 CFR 878.4835
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Galway, IE
Data sourced from openFDA. This site is unofficial and independent of the FDA.