Total clearances
3
2024-06-28 → 2026-02-24
Name variants in FDA filings: IceCure Medical , Ltd. / Icecure Medical
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| GEH |
Unit, Cryosurgical, Accessories |
Class II |
General, Plastic Surgery |
2 |
2026-02-24 |
| QXW |
Cryoablation Device For Local Treatment Of Low-Risk Breast Cancer |
Class II |
General, Plastic Surgery |
1 |
2025-10-03 |
Filings
All 510(k) clearances (3)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2026-02-24 |
K260377 |
XSense Cryoablation System with CryoProbes |
GEH |
Class II |
General, Plastic Surgery |
| 2025-10-03 |
DEN220077 |
ProSense System |
QXW |
Class II |
General, Plastic Surgery |
| 2024-06-28 |
K240892 |
XSense Cryoablation System with Cryoprobes |
GEH |
Class II |
General, Plastic Surgery |