DEN220077
- 510(k) number
- DEN220077
- Device name
- ProSense System
- Applicant
- Icecure Medical IL
- Product code
- QXW — Cryoablation Device For Local Treatment Of Low-Risk
- Decision date
- 2025-10-03
- Date received
- 2022-10-19
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- General, Plastic Surgery
Official FDA record: DEN220077
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.