QML
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Anal Fistula Closure Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4835
- Medical specialty
- General, Plastic Surgery
- Flags
- Implant
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BioHealx Anal Fistula Device (DEN240007) | Signum Surgical Limited | 2024-07-01 |
Track QML automatically
Every clearance here is in the API, with alerts when new ones post.