510(k) DEN220077
DEN220077 is an FDA 510(k) premarket notification submitted by Icecure Medical for the device "ProSense System". The FDA issued a decision of De Novo Granted on October 3, 2025. The device falls under product code QXW (Cryoablation Device For Local Treatment Of Low-Risk Breast Cancer), a Class II device regulated under 21 CFR 878.4355. Icecure Medical has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- October 3, 2025
- Date Received
- October 19, 2022
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cryoablation Device For Local Treatment Of Low-Risk Breast Cancer
- Device Class
- Class II
- Regulation Number
- 878.4355
- Review Panel
- SU
- Submission Type
A cryoablation device for local treatment of low-risk breast cancer is a prescription device that uses cold temperatures to destroy a breast tumor and its surrounding tissue. The device is intended as a local treatment and may be used with adjuvant therapies (e.g., endocrine therapy, radiation therapy) to reduce the risk of local disease progression. The device is intended for use in patients with a well-defined solid tumor (e.g., invasive ductal carcinoma) and with low risk of recurrence and metastasis, as determined by clinical risk factors consistent with the indications for use. The device is not intended to treat breast cancers with high risk of local recurrence (e.g., lobular carcinoma), patients with aggressive forms of breast cancer (e.g., breast cancers with inflammatory features), or patients in whom targeted systemic therapy is indicated.