De Novo DEN250068
- Device
- OTTAVA™ Robotic Surgical System
- Contact
- anna (inna) libman
- De Novo number
- DEN250068
- Product code
- SIR
- Regulation
- 878.4966
- Classification name
- integrated operating table-electromechanical surgical system
- Decision
- granted (DENG)
- Decision date
- 2026-07-21
- Date received
- 2025-12-18
- Classification advisory
- General & Plastic Surgery
- Review advisory
- General & Plastic Surgery
- Type
- Direct