510(k) Report

Devices descending from K230551

4 later devices reach Visual-ICE Cryoablation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250742Focused Cryotherapy SystemFocused Cryo, Inc.20250—
+1K234002ICEfx Cryoablation System (FPRCH8000-02)Boston Scientific202402
+1K232635IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)Boston Scientific202311
+2K243245IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle…Boston Scientific Corp20240—