Product code QML
- Device name
- Anal Fistula Closure Device
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4835
- Review panel
- SU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- An anal fistula closure device is a surgical implant for anal fistula repair and is intended for closure of the anal fistula. The device may be manually applied or delivered with a delivery device.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| DEN240007 | BioHealx Anal Fistula Device | Signum Surgical Limited | 2024-07-01 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| 05391546930001 | BioHealx Anal Fistula Device | SIGNUM SURGICAL LIMITED | 2025-06-25 |