Data / Medical devices / Israel / Icecure Medical Ltd.
Icecure Medical Ltd.: FDA-registered device maker in Caesarea Northern, Israel, 3 510(k) clearances
Icecure Medical Ltd. is registered with the FDA (registration 3008797959) in Caesarea Northern, Israel. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 3, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008797959
- Address
- 7 HaEshel street, POB 3163, Caesarea Northern, Israel, 3079504
- Owner or operator
- IceCure Medical Ltd. (10035292)
- Roles
- Manufacturer
- First device listed
- April 26, 2016
- Registered through
- 2026
- Brand names listed
- ProSense Cryoablation System, XSense Cryoablation System with CryoProbes
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cryoablation Device For Local Treatment Of Low-Risk Breast Cancer | QXW | 2 | Manufacturer | accessdata.fda.gov |
| Guide, Needle, Surgical | GDF | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Manufacturer | accessdata.fda.gov |
| Unit, Cryosurgical, Accessories | GEH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 3, 2025 | DEN220077 | ProSense System | QXW | Unknown | Icecure Medical | accessdata.fda.gov |
| June 28, 2024 | K240892 | XSense Cryoablation System with Cryoprobes | GEH | Substantially Equivalent | IceCure Medical , Ltd. | accessdata.fda.gov |
| December 20, 2019 | K183213 | IceSense 3, ProSense, MultiSense | GEH | Substantially Equivalent | IceCure Medical , Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 16, 2019 | 92945 | Class II | Ongoing | IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures Models: (1)FAS3000000 VAC); (2)FAS3000000-2 VAC) | Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe) | accessdata.fda.gov |
Compare with other makers
- All makers of Unit, Cryosurgical, Accessories
- All makers of Instrument, Manual, Surgical, General Use
- All makers of Guide, Needle, Surgical
Updated October 3, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.