QML — Anal Fistula Closure Device Class II
Classification Details
- Product Code
- QML
- Device Class
- Class II
- Regulation Number
- 878.4835
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN240007 | signum surgical limited | BioHealx Anal Fistula Device | July 1, 2024 |