510(k) Report

Devices descending from K052530

54 later devices reach Seednet, Seednet Gold, Cryohit, Cryothera through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183213IceSense 3, ProSense, MultiSenseIceCure Medical, Ltd.20193—
+1K102360Icesence 3IceCure Medical, Ltd.2010251
+1K060390Seednet, Seednet Gold, Cryohit, Cryo TheraGalil Medical, Ltd.2006288
+2K240892XSense Cryoablation System with CryoprobesIceCure Medical, Ltd.20242—
+2K141485Icesphere 1.5 90 Cryoblation Needle, Iceshpere 1.5 Cyoblation NeedleGalil Medical, Ltd.201433
+2K133258Trufreeze SystemCSA Medical, Inc.2014201
+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—
+3K260377XSense Cryoablation System with CryoProbesIceCure Medical, Ltd.20260—
+3K243042Co-Ablation System with Sterile Co-Ablation ProbeHygea Medical Technology Co., Ltd.20250—
+3K230551Visual-ICE Cryoablation SystemBoston Scientific Corporation20234—
+3K181741IceSphere 1.5 CX Cryoablation NeedleGalil Medical, Ltd.201821
+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
+3K143625truFreeze SystemCSA Medical, Inc.2015191
+3K140584Icerod CX Cryoablation NeedleGalil Medical, Ltd.201420—
+3K123865Visual-Ice Cryoablation SystemGalil Medical, Inc.2013111
+4K250742Focused Cryotherapy SystemFocused Cryo, Inc.20250—
+4K243245IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle…Boston Scientific Corp20240—
+4K234002ICEfx Cryoablation System (FPRCH8000-02)Boston Scientific202402
+4K231661CryoThin™ Surgical System and AccessoriesMedinux (Tianjin) Technologies Co., Ltd.20230—
+4K232635IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)Boston Scientific202311
+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—
+4K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemC2 Therapeutics, Inc.201661
+4K153489Cryocare CS Surgical SystemHealthtronics20165—
+4K152668truFreeze SystemCSA Medical, Inc.201510—
+4K150920truFreeze SystemCSA Medical, Inc.201511—
+5K201588CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe…Varian Medical Systems, Inc.20204—
+5K163684C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc.201844
+5K171398Dermal Cooling SystemR2 Dermatology,Inc20174—
+5K161202C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc.201751
+5K160273truFreeze SystemCsa Medial, Inc.20169—
+6K230271ISOLIS CryoprobeVarian Medical Systems, Inc.20231—
+6K201260Dermal Cooling SystemR2 Technologies, Inc.20203—
+6K190194C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2…Pentax Medical, A Division of Pentax of America, Inc.20193—
+6K161557truFreeze SystemCSA Medical, Inc.20168—
+7K203006R2 Dermabrasion Tip (for Dermal Cooling System)R2 Technologies, Inc.20212—
+7K203024C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon…Pentax of America, Inc.20202—
+7K162695truFreeze SystemCSA Medical, Inc.20167—
+8K213294Dermal Cooling SystemR2 Technologies, Inc.20221—
+8K212814C2 CryoBalloon Ablation SystemPentax of America, Inc.20211—
+8K171522truFreeze Rapid AV Spray KitCSA Medical, Inc.20170—
+8K163244truFreeze SystemCSA Medical, Inc.20175—
+9K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+9K240457C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)Pentax of America, Inc.20240—
+9K171626truFreeze SystemCSA Medical, Inc.20173—
+9K172041truFreeze SystemCSA Medical, Inc.20170—
+10K222272truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5…STERIS Corporation20221—
+10K201183Vortex Radial Spray CatheterCSA Medical, Inc.20200—
+11K223369truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5…STERIS Corporation20220—