510(k) DEN220077
- Device
- ProSense™ System
- Applicant
- Icecure Medical
- 510(k) number
- DEN220077
- Product code
- QXW
- Decision
- Unknown (DENG)
- Decision date
- 2025-10-03
- Date received
- 2022-10-19
- Regulation
- 878.4355
- Classification name
- Cryoablation Device For Local Treatment Of Low-Risk Breast Cancer
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Shay Levav
- Address
- 7 Ha`Eshel St., P.O. Box 3163 Caesarea IL 3079504 3079504
FDA Registration Numbers#
- 3008797959
Source Documents#
510(k) summary PDF not indicated by FDA