510(k) Report

Devices descending from K123865

11 later devices reach Visual-Ice Cryoablation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143564Visual-ICE Cryoablation System, Software Revision 1.3.1Galil Medical, Inc.2015101
+2K231661CryoThin™ Surgical System and AccessoriesMedinux (Tianjin) Technologies Co., Ltd.20230—
+2K230551Visual-ICE Cryoablation SystemBoston Scientific Corporation20234—
+2K153489Cryocare CS Surgical SystemHealthtronics20165—
+3K250742Focused Cryotherapy SystemFocused Cryo, Inc.20250—
+3K234002ICEfx Cryoablation System (FPRCH8000-02)Boston Scientific202402
+3K232635IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)Boston Scientific202311
+3K201588CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe…Varian Medical Systems, Inc.20204—
+4K243042Co-Ablation System with Sterile Co-Ablation ProbeHygea Medical Technology Co., Ltd.20250—
+4K243245IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle…Boston Scientific Corp20240—
+4K230271ISOLIS CryoprobeVarian Medical Systems, Inc.20231—