510(k) Report

Devices descending from K110946

25 later devices reach Icerod Plus 17G Cryoablation Needle, Icerod Plus 17G 90* Cryoablation Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141485Icesphere 1.5 90 Cryoblation Needle, Iceshpere 1.5 Cyoblation NeedleGalil Medical, Ltd.201433
+1K121251Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle MultipackGalil Medical, Ltd.2012221
+1K111859Iceedge 2.4 Cryoablation Needle,Iceedge 2.4 Cryoablation Needle MultipackGalil Medical, Inc.2011191
+2K181741IceSphere 1.5 CX Cryoablation NeedleGalil Medical, Ltd.201821
+2K153489Cryocare CS Surgical SystemHealthtronics20165—
+2K152133IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit…Galil Medical, Ltd.20151318
+2K143564Visual-ICE Cryoablation System, Software Revision 1.3.1Galil Medical, Inc.2015101
+2K140584Icerod CX Cryoablation NeedleGalil Medical, Ltd.201420—
+3K243245IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle…Boston Scientific Corp20240—
+3K231661CryoThin™ Surgical System and AccessoriesMedinux (Tianjin) Technologies Co., Ltd.20230—
+3K232635IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)Boston Scientific202311
+3K230551Visual-ICE Cryoablation SystemBoston Scientific Corporation20234—
+3K203032IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle…Galil Medical, Inc.20200—
+3K201588CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe…Varian Medical Systems, Inc.20204—
+3K162599IcePearl 2.1 CX L, IceForce 2.1 CX LGalil Medical, Ltd.201612
+3K161480R2 Dermal Cooling SystemR2 Dermatology20165—
+4K250742Focused Cryotherapy SystemFocused Cryo, Inc.20250—
+4K243042Co-Ablation System with Sterile Co-Ablation ProbeHygea Medical Technology Co., Ltd.20250—
+4K234002ICEfx Cryoablation System (FPRCH8000-02)Boston Scientific202402
+4K230271ISOLIS CryoprobeVarian Medical Systems, Inc.20231—
+4K171398Dermal Cooling SystemR2 Dermatology,Inc20174—
+5K201260Dermal Cooling SystemR2 Technologies, Inc.20203—
+6K203006R2 Dermabrasion Tip (for Dermal Cooling System)R2 Technologies, Inc.20212—
+7K213294Dermal Cooling SystemR2 Technologies, Inc.20221—
+8K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—