De Novo DEN250040
- Device
- SportSuite Vision Software
- Contact
- lucas dan
- De Novo number
- DEN250040
- Product code
- SIT
- Regulation
- 888.1150
- Classification name
- arthroscopic or orthopedic endoscopic intraoperative augmented reality video see-through display system
- Decision
- granted (DENG)
- Decision date
- 2026-07-17
- Date received
- 2025-09-02
- Classification advisory
- Orthopedic
- Review advisory
- Orthopedic
- Type
- Direct