Medical Device Manufacturer · IL , Caesarea

IceCure Medical , Ltd. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2010

Recent clearances: XSense Cryoablation System with CryoProbes, XSense Cryoablation System with Cryoprobes, IceSense 3, ProSense, MultiSense

4
Total
4
Cleared
0
Denied

FDA 510(k) Regulatory Record - IceCure Medical , Ltd. General & Plastic Surgery ✕

4 devices
1-4 of 4
Cleared Feb 24, 2026
XSense Cryoablation System with CryoProbes
K260377 · GEH
General & Plastic Surgery · 19d
Cleared Jun 28, 2024
XSense Cryoablation System with Cryoprobes
K240892 · GEH
General & Plastic Surgery · 88d
Cleared Dec 20, 2019
IceSense 3, ProSense, MultiSense
K183213 · GEH
General & Plastic Surgery · 396d
Cleared Nov 29, 2010
ICESENCE 3
K102360 · GEH
General & Plastic Surgery · 102d
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