510(k) Report

Devices descending from K021261

32 later devices reach Seednet System and Seednetgold System, Models GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141485Icesphere 1.5 90 Cryoblation Needle, Iceshpere 1.5 Cyoblation NeedleGalil Medical, Ltd.201433
+1K060390Seednet, Seednet Gold, Cryohit, Cryo TheraGalil Medical, Ltd.2006288
+1K031117Seednet System and Seednetgold SystemGalil Medical, Ltd.200331—
+2K193619Cry-Ac®, Cry-Ac-3®, Cry-BabyBrymill Cryogenic Systems20200—
+2K181741IceSphere 1.5 CX Cryoablation NeedleGalil Medical, Ltd.201821
+2K121251Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle MultipackGalil Medical, Ltd.2012221
+2K113860Visual-Ice Cryoablation SystemGalil Medical, Inc.2012152
+2K090978UC-Care Warming SystemUC-CARE, Ltd.20090—
+2K042667Seednet Gold with Renal Kit, Model Fprpr 3021, (Renal Kit), Fprch 2024 (Seednetgold)Galil Medical, Ltd.200429—
+3K243245IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle…Boston Scientific Corp20240—
+3K232635IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)Boston Scientific202311
+3K230551Visual-ICE Cryoablation SystemBoston Scientific Corporation20234—
+3K181153ICEfx Cryoablation SystemGalil Medical, Inc.20180—
+3K152133IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit…Galil Medical, Ltd.20151318
+3K143564Visual-ICE Cryoablation System, Software Revision 1.3.1Galil Medical, Inc.2015101
+3K140584Icerod CX Cryoablation NeedleGalil Medical, Ltd.201420—
+3K123865Visual-Ice Cryoablation SystemGalil Medical, Inc.2013111
+4K250742Focused Cryotherapy SystemFocused Cryo, Inc.20250—
+4K234002ICEfx Cryoablation System (FPRCH8000-02)Boston Scientific202402
+4K231661CryoThin™ Surgical System and AccessoriesMedinux (Tianjin) Technologies Co., Ltd.20230—
+4K203032IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle…Galil Medical, Inc.20200—
+4K162599IcePearl 2.1 CX L, IceForce 2.1 CX LGalil Medical, Ltd.201612
+4K161480R2 Dermal Cooling SystemR2 Dermatology20165—
+4K153489Cryocare CS Surgical SystemHealthtronics20165—
+5K201588CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe…Varian Medical Systems, Inc.20204—
+5K171398Dermal Cooling SystemR2 Dermatology,Inc20174—
+6K243042Co-Ablation System with Sterile Co-Ablation ProbeHygea Medical Technology Co., Ltd.20250—
+6K230271ISOLIS CryoprobeVarian Medical Systems, Inc.20231—
+6K201260Dermal Cooling SystemR2 Technologies, Inc.20203—
+7K203006R2 Dermabrasion Tip (for Dermal Cooling System)R2 Technologies, Inc.20212—
+8K213294Dermal Cooling SystemR2 Technologies, Inc.20221—
+9K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—