De Novo DEN240007
- Device
- BioHealx Anal Fistula Device
- Contact
- moshe zilversmit
- De Novo number
- DEN240007
- Product code
- QML
- Regulation
- 878.4835
- Classification name
- anal fistula closure device
- Decision
- granted (DENG)
- Decision date
- 2024-07-01
- Date received
- 2024-02-02
- Classification advisory
- General & Plastic Surgery
- Review advisory
- General & Plastic Surgery
- Type
- Direct
Current FDA Classification#
- Product code
- QML
- Device name
- Anal Fistula Closure Device
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation
- 878.4835
- Implant
- Y
- Life sustain/support
- N