FDA Product Code
FDA Product Code GEH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4350
510(k) Clearances — 264 records · page 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K141110 | CRYOCARE CS SURGICAL SYSTEM | Healthtronics | 2015-06-25 | Traditional | PDF ↗ |
| K150920 | truFreeze System | CSA Medical, Inc. | 2015-06-17 | Traditional | PDF ↗ |
| K151041 | ERBECRYO 2 Cryosurgical Unit with accessories | Erbe USA, Inc. | 2015-05-04 | Special | PDF ↗ |
| K143564 | Visual-ICE Cryoablation System, Software Revision 1.3.1 | Galil Medical, Inc. | 2015-03-05 | Special | PDF ↗ |
| K143625 | truFreeze System | CSA Medical, Inc. | 2015-01-15 | Special | PDF ↗ |
| K142441 | cryoICE croablation probe | AtriCure, Inc. | 2014-10-29 | Special | PDF ↗ |
| K141485 | ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLE | Galil Medical , Ltd. | 2014-07-02 | Special | PDF ↗ |
| K133258 | TRUFREEZE SYSTEM | CSA Medical, Inc. | 2014-06-19 | Traditional | PDF ↗ |
| K140314 | WARTIE WART REMOVER | Yonmedical BV | 2014-06-12 | Traditional | PDF ↗ |
| K140584 | ICEROD CX CRYOABLATION NEEDLE | Galil Medical , Ltd. | 2014-03-31 | Special | PDF ↗ |
| K140058 | ATRICURE CRYO MODULE SYSTEM | AtriCure, Inc. | 2014-01-24 | Special | PDF ↗ |
| K131523 | CRYOBALLOON FOCAL ABLATION SYSTEM | C2 Therapeutics | 2013-08-22 | Special | PDF ↗ |
| K130995 | NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY | Nuance Medical, LLC | 2013-06-14 | Traditional | PDF ↗ |
| K130599 | WART FREEZE | Koninklijke Utermohlen NV | 2013-06-05 | Special | PDF ↗ |
| K123865 | VISUAL-ICE CRYOABLATION SYSTEM | Galil Medical, Inc. | 2013-02-06 | Special | PDF ↗ |
| K121251 | ICEROD CX CRYOABLATION NEEDLE ICEROD CX CRYOABLATION NEEDLE MULTIPACK | Galil Medical , Ltd. | 2012-08-28 | Traditional | PDF ↗ |
| K121507 | ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE) | AtriCure, Inc. | 2012-06-06 | Traditional | PDF ↗ |
| K113860 | VISUAL-ICE CRYOABLATION SYSTEM | Galil Medical, Inc. | 2012-03-12 | Traditional | PDF ↗ |
| K113021 | TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT | CSA Medical, Inc. | 2012-02-07 | Traditional | PDF ↗ |
| K111859 | ICEEDGE 2.4 CRYOABLATION NEEDLE,ICEEDGE 2.4 CRYOABLATION NEEDLE MULTIPACK | Galil Medical, Inc. | 2011-10-07 | Traditional | PDF ↗ |
| K110754 | CRYOPEN CRYOSURGICAL SYSTEM, K102214 | Cryopen, Inc. | 2011-09-09 | Traditional | PDF ↗ |
| K112072 | ATRICURE CRYO MODULE SYSTEM | AtriCure, Inc. | 2011-08-03 | Traditional | PDF ↗ |
| K101049 | WART FREEZE | Koninklijke Utermohlen NV | 2011-06-23 | Traditional | PDF ↗ |
| K110946 | ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE | Galil Medical , Ltd. | 2011-06-21 | Special | PDF ↗ |
| K111042 | ATRICURE CRYO MODULE | AtriCure, Inc. | 2011-05-26 | Traditional | PDF ↗ |
| K103310 | CRYONIZE TM | 3jt Enterprises, LLC | 2011-02-09 | Traditional | PDF ↗ |
| K102360 | ICESENCE 3 | IceCure Medical , Ltd. | 2010-11-29 | Traditional | PDF ↗ |
| K102006 | CRYOMEGA | Stc Consulting, LLC | 2010-10-06 | Traditional | PDF ↗ |
| K101825 | CRYOBALLOON ABLATION SYSTEM | C2 Therapeutics | 2010-09-29 | Traditional | PDF ↗ |
| K101333 | CRYOCARE CS SURGICAL SYSTEM | Endocare, Inc. | 2010-06-14 | Traditional | PDF ↗ |
| K091721 | CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23 | New Medical Technologies GmbH | 2009-10-02 | Traditional | PDF ↗ |
| K090978 | UC-CARE WARMING SYSTEM | UC-CARE , Ltd. | 2009-08-10 | Traditional | PDF ↗ |
| K083493 | MYOSCIENCE CRYO-TOUCH | Myoscience, Inc. | 2009-03-20 | Traditional | PDF ↗ |
| K082074 | ATRICURE CRYO1 CRYO-ABLATION PROBE | AtriCure, Inc. | 2009-03-02 | Traditional | PDF ↗ |
| K073533 | SANARUS V2 TREATMENT SYSTEM | Sanarus Medical, Inc. | 2008-02-07 | Special | PDF ↗ |
| K072883 | ICE-SENSE | Arbel Medical , Ltd. | 2007-12-10 | Traditional | PDF ↗ |
| K072651 | CRYOSPRAY ABLATION SYSTEM, MODEL CC2-NAM | CSA Medical, Inc. | 2007-12-07 | Abbreviated | PDF ↗ |
| K072453 | CRY-AC TRACKER, MODEL(S) B-700T, AND B-800T | Brymill Corp. | 2007-12-03 | Traditional | PDF ↗ |
| K070893 | CRYOSPRAY ABLATION SYSTEM, MODEL CU 8407020500 | CSA Medical, Inc. | 2007-05-01 | Special | PDF ↗ |
| K070482 | ISIS | Galil Medical , Ltd. | 2007-03-20 | Special | PDF ↗ |
| K062896 | V2 TREATMENT SYSTEM (V2 CONSOLE, V2 ICE PROBE, V2 DEWARS) MODELS; VS3000, VP0600, VD0600 | Sanarus Medical, Inc. | 2007-01-03 | Traditional | PDF ↗ |
| K062175 | CRYOCARE CN2 SYSTEM | Endocare, Inc. | 2006-08-28 | Special | PDF ↗ |
| K061510 | SANARUS VISICA TREATMENT SYSTEM | Sanarus Medical, Inc. | 2006-07-18 | Special | PDF ↗ |
| K060859 | COMPOUND W FREEZE OFF WART REMOVAL SYSTEM | OraSure Technologies, Inc. | 2006-07-18 | Special | PDF ↗ |
| K060928 | CRYOSHAPE | Etgar Group H.M.Y.A. , Ltd. | 2006-05-22 | Traditional | PDF ↗ |
| K060390 | SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA | Galil Medical , Ltd. | 2006-04-27 | Special | PDF ↗ |
| K060555 | SPRAYGENIX CRYO ABLATION SYSTEM | Crymed Technologies, Inc. | 2006-04-21 | Traditional | PDF ↗ |
| K060279 | CRYOCARE CS SURGICAL SYSTEM | Endocare, Inc. | 2006-02-28 | Special | PDF ↗ |
| K060144 | SEEDNET/SEEDNETGOLD, CRYOTHERA AND CRYO-HIT SYSTEMS | Galil Medical , Ltd. | 2006-02-13 | Special | PDF ↗ |
| K052259 | DR. SCHOLL'S DUAL ACTION FREEZE AWAY WART REMOVER, MODEL 40406 | Schering-Plough Healthcare Products, Inc. | 2005-12-14 | Traditional | PDF ↗ |
| K052530 | SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA | Galil Medical , Ltd. | 2005-11-18 | Traditional | PDF ↗ |
| K052861 | MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM , MODELS VS2000 | Sanarus Medical, Inc. | 2005-11-15 | Special | PDF ↗ |
| K051509 | ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES | Erbe USA, Inc. | 2005-07-27 | Traditional | PDF ↗ |
| K051052 | SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM) | Galil Medical , Ltd. | 2005-05-06 | Special | PDF ↗ |
| K050347 | MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM | Endocare, Inc. | 2005-02-25 | Traditional | PDF ↗ |
| K042667 | SEEDNET GOLD WITH RENAL KIT, MODEL FPRPR 3021, (RENAL KIT), FPRCH 2024 (SEEDNETGOLD) | Galil Medical , Ltd. | 2004-10-14 | Special | PDF ↗ |
| K041783 | POLAR WAND | Chek-Med Systems | 2004-09-28 | Traditional | PDF ↗ |
| K040809 | CRYMED CRYO-ABLATOR | Crymed Technologies, Inc. | 2004-05-21 | Traditional | PDF ↗ |
| K032271 | WARTNER WART REMOVAL SYSTEM, MODEL 66715 82000 (PRODUCT CODE NUMBER 52E022) | Wartner USA B.V. | 2003-09-10 | Traditional | PDF ↗ |
| K031697 | DR. SCHOLL'S FREEZE AWAY WART REMOVER, MODEL 40226 | Schering-Plough Healthcare Products, Inc. | 2003-08-29 | Traditional | PDF ↗ |
| K032333 | CRYOCARE CS SURGICAL SYSTEM | Endocare, Inc. | 2003-08-12 | Traditional | PDF ↗ |
| K030838 | WARTNER PRO | Wartner Medical Products | 2003-06-27 | Traditional | PDF ↗ |
| K031117 | SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM | Galil Medical , Ltd. | 2003-05-23 | Special | PDF ↗ |
| K030303 | FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC CRYOABLATION CRYOCONSOLE | Cryocath Technologies, Inc. | 2003-04-29 | Traditional | PDF ↗ |
| K023487 | HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME | OraSure Technologies, Inc. | 2003-03-20 | Traditional | PDF ↗ |
| K024009 | CRYOPROBE | H&O Equipments, Nv/Sa | 2003-03-20 | Traditional | PDF ↗ |
| K023757 | CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20 | Endocare, Inc. | 2002-12-05 | Special | PDF ↗ |
| K022314 | SANARUS VISICA TREATMENT SYSTEM | Sanarus Medical, Inc. | 2002-10-15 | Traditional | PDF ↗ |
| K021387 | POLAR WAND | Chek-Med Systems | 2002-07-31 | Traditional | PDF ↗ |
| K021261 | SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM, MODELS GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3 | Galil Medical , Ltd. | 2002-07-03 | Traditional | PDF ↗ |
| K021211 | MODIFICATION TO SANARUS VISICA TREATMENT SYSTEM | Sanarus Medical, Inc. | 2002-06-26 | Special | PDF ↗ |
| K012214 | CRYOPEN AND ACCESSORIES | Cimex Biotech, LLC | 2002-04-26 | Traditional | PDF ↗ |
| K020605 | SANARUS VISICA TREATMENT SYSTEM | Sanarus Medical, Inc. | 2002-03-08 | Traditional | PDF ↗ |
| K011708 | MODIFICATION TO WARTNER WART REMOVAL SYSTEM | Wartner Medical Products | 2002-02-20 | Traditional | PDF ↗ |
| K011950 | SEEDNET, MODEL FP6T5, FP5T5, FP5T3 | Galil Medical , Ltd. | 2002-01-29 | Traditional | PDF ↗ |
| K011074 | CRYOCARE SURGICAL SYSTEM | Endocare, Inc. | 2002-01-25 | Traditional | PDF ↗ |
| K012497 | CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1 | Galil Medical , Ltd. | 2001-10-30 | Traditional | PDF ↗ |
| K003811 | CRYOCARE SURGICAL SYSTEM | Endocare, Inc. | 2001-10-11 | Traditional | PDF ↗ |
| K011073 | CRYOPLAN SYSTEM | Cryomedical Sciences, Inc. | 2001-08-22 | Traditional | PDF ↗ |
| K010991 | SEEDNET, MODELS FP6T5, FP5T5, FP5T3 | Galil Medical , Ltd. | 2001-05-03 | Special | PDF ↗ |
| K002714 | WARTNER WART REMOVAL SYSTEM | Wartner Medical Products | 2000-11-28 | Traditional | PDF ↗ |
| K002615 | SURGICAL SYSTEM WITH CRYOGUIDE | Endocare, Inc. | 2000-11-13 | Traditional | PDF ↗ |
| K003065 | SEEDNET, MODEL EP6T5, EP5E5 | Galil Medical , Ltd. | 2000-10-31 | Special | PDF ↗ |
| K993965 | CRYO-HIT | Galil Medical , Ltd. | 2000-02-18 | Traditional | PDF ↗ |
| K991792 | CRYO-MONO CRYOGENIC SYSTEM, MODEL CRYO-MONO WITH TUF PROBE | Influence, Inc. | 1999-08-12 | Traditional | PDF ↗ |
| K991517 | CRYO-HIT II, MODELS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 | Galil Medical , Ltd. | 1999-07-27 | Traditional | PDF ↗ |
| K991272 | CRYO-HIT,MODELS ED1TO, EPITI, EP2TI, EP2T2, EP3T3, EP4T2, EPT3, EP4T4,EP5T2, EP5T3, EP5T5, EP6T5,EP7T3,EP7T5,EP8T3,AND E | Galil Medical , Ltd. | 1999-07-12 | Traditional | PDF ↗ |
| K991122 | CRYO-MONO CRYOGRNIC SYSTEM | Influence, Inc. | 1999-07-01 | Traditional | PDF ↗ |
| K990877 | HISTOFREEZER DEVICE | OraSure Technologies, Inc. | 1999-06-14 | Traditional | PDF ↗ |
| K982506 | VERRUCA-FREEZE CRYOSURGERY DELIVERY SYSTEM | Cryosurgery, Inc. | 1999-01-27 | Traditional | PDF ↗ |
| K982280 | CRYOPRO MAXI AND CRYOPRO MINI | Cortex Technology Aps | 1998-11-25 | Traditional | PDF ↗ |
| K982358 | HISTOFREEZER DEVICE | OraSure Technologies, Inc. | 1998-10-02 | Traditional | PDF ↗ |
| K982055 | ACCUPROBE 800 SERIES MODEL NUMBERS : 810, 820, 830, 840, 850, 860, 870 AND 880 | Cryomedical Sciences, Inc. | 1998-09-08 | Traditional | PDF ↗ |
| K980670 | CMS BLIZZARD 700 SERIES MODELS 710, 711, 712, 720, 721 AND 722 | Cryomedical Sciences, Inc. | 1998-07-17 | Traditional | PDF ↗ |
| K980668 | CMS BLIZZARD 700 SERIES MODELS 730, 740,750,760,770,780 & 790 | Cryomedical Sciences, Inc. | 1998-07-17 | Traditional | PDF ↗ |
| K980739 | HISTOFREEZER/ 17% SALICYLIC ACID-VERRUCA PLANTARIS | OraSure Technologies, Inc. | 1998-05-26 | Traditional | PDF ↗ |
| K980110 | ENDOCRE CRYOCARE CRYOSURGICAL SYSTEM | Endocare, Inc. | 1998-04-10 | Traditional | PDF ↗ |
| K973686 | ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM | Endocare, Inc. | 1997-12-22 | Traditional | PDF ↗ |
| K971392 | HISTOFREEZER VERRUCA PLANA | OraSure Technologies, Inc. | 1997-10-21 | Traditional | PDF ↗ |
| K972662 | CRYOGEN CRYOSURGICAL SYSTEM | Cryogen, Inc. | 1997-10-01 | Traditional | PDF ↗ |
Product code GEH · Class II · General, Plastic Surgery. Data: openFDA.