De Novo DEN220077
- Device
- ProSense™ System
- Contact
- shay levav
- De Novo number
- DEN220077
- Product code
- QXW
- Regulation
- 878.4355
- Classification name
- cryoablation device for local treatment of low-risk breast cancer
- Decision
- granted (DENG)
- Decision date
- 2025-10-03
- Date received
- 2022-10-19
- Classification advisory
- General & Plastic Surgery
- Review advisory
- General & Plastic Surgery
- Type
- Direct
Current FDA Classification#
- Product code
- QXW
- Device name
- Cryoablation Device For Local Treatment Of Low-Risk Breast Cancer
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation
- 878.4355
- Implant
- N
- Life sustain/support
- N