FDA 510(k) Applications for Medical Device Product Code "GEH"
(Unit, Cryosurgical, Accessories)

FDA 510(k) Number Applicant Device Name Decision Date
K103310 3JT ENTERPRISES LLC CRYONIZE TM 02/09/2011
K072883 ARBEL MEDICAL LTD. ICE-SENSE 12/10/2007
K190356 Arrinex, Inc ClariFix 02/26/2019
K160669 ARRINEX, INC. ClariFix Device 06/24/2016
K162608 ARRINEX, INC. ClariFix Device 02/14/2017
K152337 ATRICURE, INC cryoFORM cryoICE cryoablation probe 03/22/2016
K111042 ATRICURE, INC. ATRICURE CRYO MODULE 05/26/2011
K112072 ATRICURE, INC. ATRICURE CRYO MODULE SYSTEM 08/03/2011
K140058 ATRICURE, INC. ATRICURE CRYO MODULE SYSTEM 01/24/2014
K121507 ATRICURE, INC. ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE) 06/06/2012
K082074 ATRICURE, INC. ATRICURE CRYO1 CRYO-ABLATION PROBE 03/02/2009
K180137 AtriCure, Inc. AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF) 02/15/2018
K142441 ATRICURE, INC. cryoICE croablation probe 10/29/2014
K182392 B.M. Tech. Worldwide Co., Ltd. Frozen C 10/30/2018
K221897 BIBAWO Medical A/S Hydrozid Precise 05/30/2023
K964047 BIODERMIS CORP. CRYOSIL SILICONE GEL SHEETING 03/19/1997
K961219 BOSTON SCIENTIFIC CORP. PERCUTANEOUS INTRODUCER SYSTEM 06/21/1996
K230551 Boston Scientific Corporation Visual-ICE Cryoablation System 08/08/2023
K180211 Bovie Medical Corp. Freezpoint 03/21/2018
K072453 BRYMILL CORP. CRY-AC TRACKER, MODEL(S) B-700T, AND B-800T 12/03/2007
K193619 Brymill Cryogenic Systems Cry-Ac«, Cry-Ac-3«, Cry-Baby 03/25/2020
K101825 C2 THERAPEUTICS CRYOBALLOON ABLATION SYSTEM 09/29/2010
K131523 C2 THERAPEUTICS CRYOBALLOON FOCAL ABLATION SYSTEM 08/22/2013
K161202 C2 THERAPEUTICS, INC. C2 Cryoballoon Ablation System 01/05/2017
K163684 C2 Therapeutics, Inc. C2 CryoBalloon Ablation System 01/23/2018
K160994 C2 THERAPEUTICS, INC. C2 CryoBalloon Focal Pear Catheter 05/19/2016
K152329 C2 Therapeutics, Inc. Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System 04/13/2016
K153541 C2 THERAPEUTICS, INC. Coldplay CryoBalloon« Ablation System 01/07/2016
K151054 C2 Therapeutics, Inc. Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System 07/07/2015
K954872 CANDELA LASER CORP. CANDELA CRYO-PROBE HOLDER 02/05/1996
K955011 CANDELA LASER CORP. CANDELA HCS 2000 URETHERAL WARMER CATHETER 04/03/1996
K021387 CHEK-MED SYSTEMS POLAR WAND 07/31/2002
K041783 CHEK-MED SYSTEMS POLAR WAND 09/28/2004
K012214 CIMEX BIOTECH, LLC. CRYOPEN AND ACCESSORIES 04/26/2002
K161296 COOL RENEWAL, LLC Cool Renewal 07/06/2016
K982280 CORTEX TECHNOLOGY APS CRYOPRO MAXI AND CRYOPRO MINI 11/25/1998
K172049 Cry IQ AB CryoIQ DERM, CryoIQ PRO, CryoIQ EquiMED 08/30/2017
K040809 CRYMED TECHNOLOGIES, INC. CRYMED CRYO-ABLATOR 05/21/2004
K060555 CRYMED TECHNOLOGIES, INC. SPRAYGENIX CRYO ABLATION SYSTEM 04/21/2006
K030303 CRYOCATH TECHNOLOGIES, INC. FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC CRYOABLATION CRYOCONSOLE 04/29/2003
K190407 CryoConcepts LP CryoLab 04/22/2019
K172769 CryoConcepts LP CryOmega Flexx 11/30/2017
K183601 CryoConcepts LP CryoTouch 04/18/2019
K211099 CryoConcepts LP FreezeÆn Clear Skin Clinic Warts & Tags 06/17/2022
K170810 CRYOFOS Medical Gmbh CRYOFOS 09/27/2017
K964971 CRYOGEN, INC. CRYOGEN CRYOSURGICAL SYSTEM 03/28/1997
K972662 CRYOGEN, INC. CRYOGEN CRYOSURGICAL SYSTEM 10/01/1997
K982055 CRYOMEDICAL SCIENCES, INC. ACCUPROBE 800 SERIES MODEL NUMBERS : 810, 820, 830, 840, 850, 860, 870 AND 880 09/08/1998
K964336 CRYOMEDICAL SCIENCES, INC. CMS ACCUPROBE 610, 620, 630, 640, 650, 660, 670, 680 03/20/1997
K980670 CRYOMEDICAL SCIENCES, INC. CMS BLIZZARD 700 SERIES MODELS 710, 711, 712, 720, 721 AND 722 07/17/1998
K980668 CRYOMEDICAL SCIENCES, INC. CMS BLIZZARD 700 SERIES MODELS 730, 740,750,760,770,780 & 790 07/17/1998
K970995 CRYOMEDICAL SCIENCES, INC. CMS CRYOLITE 07/07/1997
K011073 CRYOMEDICAL SCIENCES, INC. CRYOPLAN SYSTEM 08/22/2001
K110754 CRYOPEN, INC. CRYOPEN CRYOSURGICAL SYSTEM, K102214 09/09/2011
K982506 CRYOSURGERY, INC. VERRUCA-FREEZE CRYOSURGERY DELIVERY SYSTEM 01/27/1999
K955083 CRYOSURGERY, INC. VERRUCA-FREEZE CRYOSURGICAL DELIVERY SYSTEM (MODIFICATION) 02/08/1996
K160273 CSA MEDIAL, INC. truFreeze System 03/25/2016
K072651 CSA MEDICAL, INC. CRYOSPRAY ABLATION SYSTEM, MODEL CC2-NAM 12/07/2007
K070893 CSA MEDICAL, INC. CRYOSPRAY ABLATION SYSTEM, MODEL CU 8407020500 05/01/2007
K171522 CSA Medical, Inc. truFreeze Rapid AV Spray Kit 07/14/2017
K133258 CSA MEDICAL, INC. TRUFREEZE SYSTEM 06/19/2014
K143625 CSA MEDICAL, INC. truFreeze System 01/15/2015
K150920 CSA MEDICAL, INC. truFreeze System 06/17/2015
K152668 CSA MEDICAL, INC. truFreeze System 10/14/2015
K161557 CSA MEDICAL, INC. truFreeze System 07/26/2016
K162695 CSA MEDICAL, INC. truFreeze System 10/25/2016
K163244 CSA MEDICAL, INC. truFreeze System 05/24/2017
K171626 CSA Medical, Inc. truFreeze System 08/30/2017
K172041 CSA Medical, Inc. truFreeze System 07/27/2017
K113021 CSA MEDICAL, INC. TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT 02/07/2012
K201183 CSA Medical, Inc. Vortex Radial Spray Catheter 12/07/2020
K971216 DERMATOLOGIC LAB & SUPPLY, INC. FRIGIDERM FRIGISPRAY 05/29/1997
K190747 DGI Technologies Claritag 10/31/2019
K222356 DGI Technologies Claritag Advanced 05/18/2023
K954703 ELLMAN INTL., INC. MEDI-FRIG 02/08/1996
K062175 ENDOCARE, INC. CRYOCARE CN2 SYSTEM 08/28/2006
K032333 ENDOCARE, INC. CRYOCARE CS SURGICAL SYSTEM 08/12/2003
K060279 ENDOCARE, INC. CRYOCARE CS SURGICAL SYSTEM 02/28/2006
K101333 ENDOCARE, INC. CRYOCARE CS SURGICAL SYSTEM 06/14/2010
K003811 ENDOCARE, INC. CRYOCARE SURGICAL SYSTEM 10/11/2001
K011074 ENDOCARE, INC. CRYOCARE SURGICAL SYSTEM 01/25/2002
K023757 ENDOCARE, INC. CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20 12/05/2002
K963826 ENDOCARE, INC. ENDOCARE CRYCARE CRYOSURGICAL SYSTEM 12/18/1996
K973686 ENDOCARE, INC. ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM 12/22/1997
K963970 ENDOCARE, INC. ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM URETHRAL WARMING SYSTEM 02/25/1997
K980110 ENDOCARE, INC. ENDOCRE CRYOCARE CRYOSURGICAL SYSTEM 04/10/1998
K050347 ENDOCARE, INC. MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM 02/25/2005
K002615 ENDOCARE, INC. SURGICAL SYSTEM WITH CRYOGUIDE 11/13/2000
K190651 Erbe Elektromedizin GmbH ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter 01/07/2020
K051509 ERBE USA, INC. ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES 07/27/2005
K151041 ERBE USA, INC. ERBECRYO 2 Cryosurgical Unit with accessories 05/04/2015
K060928 ETGAR GROUP H.M.Y.A. LTD. CRYOSHAPE 05/22/2006
K111859 GALIL MEDICAL INC. ICEEDGE 2.4 CRYOABLATION NEEDLE,ICEEDGE 2.4 CRYOABLATION NEEDLE MULTIPACK 10/07/2011
K181153 Galil Medical Inc. ICEfx Cryoablation System 05/15/2018
K203032 Galil Medical Inc. IcePearl 2.1 CX 90░ Needle, IcePearl 2.1 CX L 90░ Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90░ Needle, IceFORCE 2.1 CX L 90░ Needle, IceFORCE 2.1 CX Needle 11/02/2020
K113860 GALIL MEDICAL INC. VISUAL-ICE CRYOABLATION SYSTEM 03/12/2012
K123865 GALIL MEDICAL INC. VISUAL-ICE CRYOABLATION SYSTEM 02/06/2013
K143564 GALIL MEDICAL INC. Visual-ICE Cryoablation System, Software Revision 1.3.1 03/05/2015
K173037 Galil Medical Inc. Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel 11/21/2017
K152133 GALIL MEDICAL LTD IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE 2.1 CX Cryoablation Needle, IceFORCE 2.1 CX Prostate Cryoablation Kit Visual-ICE System 08/28/2015
K993965 GALIL MEDICAL LTD. CRYO-HIT 02/18/2000
K991517 GALIL MEDICAL LTD. CRYO-HIT II, MODELS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 07/27/1999
K012497 GALIL MEDICAL LTD. CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1 10/30/2001
K991272 GALIL MEDICAL LTD. CRYO-HIT,MODELS ED1TO, EPITI, EP2TI, EP2T2, EP3T3, EP4T2, EPT3, EP4T4,EP5T2, EP5T3, EP5T5, EP6T5,EP7T3,EP7T5,EP8T3,AND E 07/12/1999
K162599 GALIL MEDICAL LTD. IcePearl 2.1 CX L, IceForce 2.1 CX L 10/11/2016
K140584 GALIL MEDICAL LTD. ICEROD CX CRYOABLATION NEEDLE 03/31/2014
K121251 GALIL MEDICAL LTD. ICEROD CX CRYOABLATION NEEDLE ICEROD CX CRYOABLATION NEEDLE MULTIPACK 08/28/2012
K110946 GALIL MEDICAL LTD. ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE 06/21/2011
K141485 GALIL MEDICAL LTD. ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLE 07/02/2014
K181741 Galil Medical Ltd. IceSphere 1.5 CX Cryoablation Needle 07/30/2018
K070482 GALIL MEDICAL LTD. ISIS 03/20/2007
K051052 GALIL MEDICAL LTD. SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM) 05/06/2005
K042667 GALIL MEDICAL LTD. SEEDNET GOLD WITH RENAL KIT, MODEL FPRPR 3021, (RENAL KIT), FPRCH 2024 (SEEDNETGOLD) 10/14/2004
K031117 GALIL MEDICAL LTD. SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM 05/23/2003
K021261 GALIL MEDICAL LTD. SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM, MODELS GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3 07/03/2002
K003065 GALIL MEDICAL LTD. SEEDNET, MODEL EP6T5, EP5E5 10/31/2000
K011950 GALIL MEDICAL LTD. SEEDNET, MODEL FP6T5, FP5T5, FP5T3 01/29/2002
K010991 GALIL MEDICAL LTD. SEEDNET, MODELS FP6T5, FP5T5, FP5T3 05/03/2001
K060390 GALIL MEDICAL LTD. SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA 04/27/2006
K052530 GALIL MEDICAL LTD. SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA 11/18/2005
K060144 GALIL MEDICAL LTD. SEEDNET/SEEDNETGOLD, CRYOTHERA AND CRYO-HIT SYSTEMS 02/13/2006
K024009 H&O EQUIPMENTS NV/SA CRYOPROBE 03/20/2003
K161615 H&O EQUIPMENTS, NV/SA Accurett 08/23/2016
K153489 Health Tronics Cryocare CS Surgical System 02/05/2016
K141110 HEALTHTRONICS CRYOCARE CS SURGICAL SYSTEM 06/25/2015
K151968 HEALTHTRONICS Cryocare CS-3 Surgical System version 5 09/09/2015
K102360 ICECURE MEDICAL LTD. ICESENCE 3 11/29/2010
K183213 IceCure Medical LTD. IceSense 3, ProSense, MultiSense 12/20/2019
K991792 INFLUENCE, INC. CRYO-MONO CRYOGENIC SYSTEM, MODEL CRYO-MONO WITH TUF PROBE 08/12/1999
K991122 INFLUENCE, INC. CRYO-MONO CRYOGRNIC SYSTEM 07/01/1999
K152203 KONINKLIJKE (ROYAL) UTERMOHLEN UTERMOHLEN CRYO PROFESSIONAL 11/06/2015
K130599 KONINKLIJKE UTERMOHLEN NV WART FREEZE 06/05/2013
K101049 KONINKLIJKE UTERMOHLEN NV WART FREEZE 06/23/2011
K201740 MediLink A/S Hydrozid 07/07/2021
K172373 Medtech Products Inc. Compound W Nitro-Freeze 11/02/2017
K161294 MEDTECH PRODUCTS INC. Compound W Wart Removal System Dual Power 09/15/2016
K083493 MYOSCIENCE INC MYOSCIENCE CRYO-TOUCH 03/20/2009
K091721 NEW MEDICAL TECHNOLOGIES GMBH CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23 10/02/2009
K161337 NUANCE MEDICAL, LLC CryoDose H or Similar 07/12/2016
K210310 Nuance Medical, LLC CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit 10/22/2021
K130995 NUANCE MEDICAL, LLC NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY 06/14/2013
K060859 ORASURE TECHNOLOGIES, INC. COMPOUND W FREEZE OFF WART REMOVAL SYSTEM 07/18/2006
K982358 ORASURE TECHNOLOGIES, INC. HISTOFREEZER DEVICE 10/02/1998
K990877 ORASURE TECHNOLOGIES, INC. HISTOFREEZER DEVICE 06/14/1999
K971392 ORASURE TECHNOLOGIES, INC. HISTOFREEZER VERRUCA PLANA 10/21/1997
K023487 ORASURE TECHNOLOGIES, INC. HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME 03/20/2003
K980739 ORASURE TECHNOLOGIES, INC. HISTOFREEZER/ 17% SALICYLIC ACID-VERRUCA PLANTARIS 05/26/1998
K190194 PENTAX Medical, A Division of PENTAX of America, Inc. C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge 05/31/2019
K212814 PENTAX of America, Inc. C2 CryoBalloon Ablation System 11/29/2021
K203024 PENTAX of America, Inc. C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge 11/24/2020
K970992 PREMIER DENTAL PRODUCTS CO. PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS 06/17/1997
K201366 Pronova Laboratories BV Forwarts 01/21/2021
K161480 R2 Dermatology R2 Dermal Cooling System 10/05/2016
K171398 R2 Dermatology ,Inc Dermal Cooling System 07/06/2017
K201260 R2 Technologies, Inc. Dermal Cooling System 09/24/2020
K203481 Recens Medical Inc. CryoVIVE 05/13/2021
K220674 RecensMedical Inc. TargetCool 03/31/2022
K221234 RecensMedical Inc. TargetCool 07/22/2022
K230599 RecensMedical, Inc. TargetCoolÖ 06/22/2023
K021211 SANARUS MEDICAL, INC. MODIFICATION TO SANARUS VISICA TREATMENT SYSTEM 06/26/2002
K052861 SANARUS MEDICAL, INC. MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM , MODELS VS2000 11/15/2005
K073533 SANARUS MEDICAL, INC. SANARUS V2 TREATMENT SYSTEM 02/07/2008
K061510 SANARUS MEDICAL, INC. SANARUS VISICA TREATMENT SYSTEM 07/18/2006
K020605 SANARUS MEDICAL, INC. SANARUS VISICA TREATMENT SYSTEM 03/08/2002
K022314 SANARUS MEDICAL, INC. SANARUS VISICA TREATMENT SYSTEM 10/15/2002
K062896 SANARUS MEDICAL, INC. V2 TREATMENT SYSTEM (V2 CONSOLE, V2 ICE PROBE, V2 DEWARS) MODELS; VS3000, VP0600, VD0600 01/03/2007
K052259 SCHERING-PLOUGH HEALTHCARE PRODUCTS, INC. DR. SCHOLL'S DUAL ACTION FREEZE AWAY WART REMOVER, MODEL 40406 12/14/2005
K031697 SCHERING-PLOUGH HEALTHCARE PRODUCTS, INC. DR. SCHOLL'S FREEZE AWAY WART REMOVER, MODEL 40226 08/29/2003
K102006 STC CONSULTING LLC CRYOMEGA 10/06/2010
K222272 STERIS Corporation truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 08/18/2022
K223369 STERIS Corporation truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 12/02/2022
K210529 The OTC Lab Healthcare B.V. Dr. Yglo Wart Remover 05/06/2021
K090978 UC-CARE LTD. UC-CARE WARMING SYSTEM 08/10/2009
K960387 UROS CORP. UROSPROBE SYSTEM, MODEL 1000 04/01/1996
K201588 Varian Medical Systems, Inc. CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice 08/11/2020
K230271 Varian Medical Systems, Inc. ISOLIS Cryoprobe 03/28/2023
K211149 Varian Medical Systems, Inc. Urethral Warming Catheter Kit 01/05/2022
K011708 WARTNER MEDICAL PRODUCTS MODIFICATION TO WARTNER WART REMOVAL SYSTEM 02/20/2002
K030838 WARTNER MEDICAL PRODUCTS WARTNER PRO 06/27/2003
K002714 WARTNER MEDICAL PRODUCTS WARTNER WART REMOVAL SYSTEM 11/28/2000
K032271 WARTNER USA B.V. WARTNER WART REMOVAL SYSTEM, MODEL 66715 82000 (PRODUCT CODE NUMBER 52E022) 09/10/2003
K140314 YONMEDICAL BV WARTIE WART REMOVER 06/12/2014
K151309 YOUMEDICAL CORP BV Wartie Advanced Wart Remover or other proprietary name 08/14/2015
K193665 Yozma BmTech Co., Ltd. Frozen N 05/28/2020


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