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 |
| K234002 | Boston Scientific | ICEfx Cryoablation System (FPRCH8000-02) | 03/13/2024 |
| K232635 | Boston Scientific | IceSeed 1.5 CX 90║ Needle (H7493967433170); IceSeed 1.5 CX S 90║ Needle (H7493967233100) | 11/22/2023 |
| K243245 | Boston Scientific Corp. | IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) | 10/18/2024 |
| 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 |
| K242625 | CryoConcepts LP | Freeze Point & Private Label Versions | 10/25/2024 |
| K211099 | CryoConcepts LP | FreezeÆn Clear Skin Clinic Warts & Tags | 06/17/2022 |
| K240106 | CryoConcepts LP | Histofreezer V | 06/10/2024 |
| K251493 | CryoConcepts LP | Skin Clinic Freeze Point for Warts and Skin Tags | 05/22/2025 |
| K242932 | CryoConcepts LP | Skin Clinic Nitro Clear Wart Remover | 04/15/2025 |
| 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 |
| K243487 | CryoSurgery, Inc. | CryoFreeze Wart and Skin Tag Remover | 03/13/2025 |
| K982506 | CRYOSURGERY, INC. | VERRUCA-FREEZE CRYOSURGERY DELIVERY SYSTEM | 01/27/1999 |
| K955083 | CRYOSURGERY, INC. | VERRUCA-FREEZE CRYOSURGICAL DELIVERY SYSTEM (MODIFICATION) | 02/08/1996 |
| K243454 | CryoSurgery, Inc. | Verruca-Freeze H | 12/03/2024 |
| K233347 | CryoSurgery, Inc. | Verruca-Freeze« H | 12/04/2023 |
| 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 |
| K240776 | Endocision Technologies Inc. | Celsio Flexible Cryocatheter System | 09/24/2024 |
| 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 |
| K243042 | Hygea Medical Technology Co., Ltd. | Co-Ablation System with Sterile Co-Ablation Probe | 01/29/2025 |
| K102360 | ICECURE MEDICAL LTD. | ICESENCE 3 | 11/29/2010 |
| K183213 | IceCure Medical LTD. | IceSense 3, ProSense, MultiSense | 12/20/2019 |
| K240892 | IceCure Medical Ltd. | XSense Cryoablation System with Cryoprobes | 06/28/2024 |
| 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 |
| K242288 | Medical Brands Laboratories B.V. | Advanced Cryo Wart Remover | 01/21/2025 |
| K201740 | MediLink A/S | Hydrozid | 07/07/2021 |
| K231661 | Medinux (Tianjin) Technologies Co., Ltd. | CryoThinÖ Surgical System and Accessories | 11/27/2023 |
| K172373 | Medtech Products Inc. | Compound W Nitro-Freeze | 11/02/2017 |
| K242803 | Medtech Products Inc. | Compound W Skin Tag Remover | 11/06/2024 |
| 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 |
| K240457 | PENTAX of America, Inc. | C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) | 07/24/2024 |
| 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 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
