510(k) Report

Devices descending from K121251

22 later devices reach Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle Multipack through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181741IceSphere 1.5 CX Cryoablation NeedleGalil Medical, Ltd.201821
+1K152133IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit…Galil Medical, Ltd.20151318
+1K143564Visual-ICE Cryoablation System, Software Revision 1.3.1Galil Medical, Inc.2015101
+1K140584Icerod CX Cryoablation NeedleGalil Medical, Ltd.201420—
+2K243245IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle…Boston Scientific Corp20240—
+2K231661CryoThin™ Surgical System and AccessoriesMedinux (Tianjin) Technologies Co., Ltd.20230—
+2K232635IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)Boston Scientific202311
+2K230551Visual-ICE Cryoablation SystemBoston Scientific Corporation20234—
+2K203032IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle…Galil Medical, Inc.20200—
+2K162599IcePearl 2.1 CX L, IceForce 2.1 CX LGalil Medical, Ltd.201612
+2K161480R2 Dermal Cooling SystemR2 Dermatology20165—
+2K153489Cryocare CS Surgical SystemHealthtronics20165—
+3K250742Focused Cryotherapy SystemFocused Cryo, Inc.20250—
+3K234002ICEfx Cryoablation System (FPRCH8000-02)Boston Scientific202402
+3K201588CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe…Varian Medical Systems, Inc.20204—
+3K171398Dermal Cooling SystemR2 Dermatology,Inc20174—
+4K243042Co-Ablation System with Sterile Co-Ablation ProbeHygea Medical Technology Co., Ltd.20250—
+4K230271ISOLIS CryoprobeVarian Medical Systems, Inc.20231—
+4K201260Dermal Cooling SystemR2 Technologies, Inc.20203—
+5K203006R2 Dermabrasion Tip (for Dermal Cooling System)R2 Technologies, Inc.20212—
+6K213294Dermal Cooling SystemR2 Technologies, Inc.20221—
+7K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—