510(k) DEN240007
DEN240007 is an FDA 510(k) premarket notification submitted by Signum Surgical Limited for the device "BioHealx Anal Fistula Device". The FDA issued a decision of De Novo Granted on July 1, 2024. The device falls under product code QML (Anal Fistula Closure Device), a Class II device regulated under 21 CFR 878.4835.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- July 1, 2024
- Date Received
- February 2, 2024
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Anal Fistula Closure Device
- Device Class
- Class II
- Regulation Number
- 878.4835
- Review Panel
- SU
- Submission Type
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.