510(k) Report

Devices descending from K183213

3 later devices reach IceSense 3, ProSense, MultiSense through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240892XSense Cryoablation System with CryoprobesIceCure Medical, Ltd.20242—
+2K260377XSense Cryoablation System with CryoProbesIceCure Medical, Ltd.20260—
+2K243042Co-Ablation System with Sterile Co-Ablation ProbeHygea Medical Technology Co., Ltd.20250—