QML · Anal Fistula Closure Device
General, Plastic Surgery · 21 CFR 878.4835 · Class 2
Overview
| Product Code | QML |
|---|---|
| Device Name | Anal Fistula Closure Device |
| Regulation | 21 CFR 878.4835 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
Identification
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN240007 | BioHealx Anal Fistula Device | Signum Surgical Limited | Jul 1, 2024 | DENG |
Top Applicants
- Signum Surgical Limited — 1 clearance
