De Novo DEN250034
- Device
- Claria System
- Contact
- brian fisher
- De Novo number
- DEN250034
- Product code
- SIM
- Regulation
- 884.4075
- Classification name
- gynecologic power morcellator and containment system
- Decision
- granted (DENG)
- Decision date
- 2026-07-02
- Date received
- 2025-08-07
- Classification advisory
- Obstetrics/Gynecology
- Review advisory
- Obstetrics/Gynecology
- Type
- Direct