Icecure Medical Ltd
FDA Regulatory Profile
Icecure Medical Ltd appears in FDA public data with 1 recall, 5 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-2650-2023, Class II) was initiated on September 16, 2019. Its most recent 510(k) clearance was granted on February 24, 2026.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 5
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2650-2023 | Class II | IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical p | September 16, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K260377 | XSense Cryoablation System with CryoProbes | February 24, 2026 |
| DEN220077 | ProSense System | October 3, 2025 |
| K240892 | XSense Cryoablation System with Cryoprobes | June 28, 2024 |
| K183213 | IceSense 3, ProSense, MultiSense | December 20, 2019 |
| K102360 | ICESENCE 3 | November 29, 2010 |