Unit, Cryosurgical, Accessories
FDA product code GEH · 247 cleared devices
Class 2
General, Plastic Surgery
- Regulation
- 21 CFR 878.4350
- Review panel
- SU
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1976-10-29 – 2026-09-02
GEH
2012-03-12
GEH
2012-02-07
TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT
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GEH
2011-10-07
ICEEDGE 2.4 CRYOABLATION NEEDLE,ICEEDGE 2.4 CRYOABLATION NEEDLE MULTIPACK
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GEH
2011-09-09
CRYOPEN CRYOSURGICAL SYSTEM, K102214
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GEH
2011-08-03
ATRICURE CRYO MODULE SYSTEM
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GEH
2011-06-23
WART FREEZE
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GEH
2011-06-21
ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE
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GEH
2011-05-26
ATRICURE CRYO MODULE
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GEH
2011-02-09
CRYONIZE TM
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GEH
2010-11-29
ICESENCE 3
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GEH
2010-10-06
CRYOMEGA
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GEH
2010-09-29
CRYOBALLOON ABLATION SYSTEM
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GEH
2010-06-14
CRYOCARE CS SURGICAL SYSTEM
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GEH
2009-10-02
CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23
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GEH
2009-08-10
UC-CARE WARMING SYSTEM
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GEH
2009-03-20
MYOSCIENCE CRYO-TOUCH
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GEH
2009-03-02
ATRICURE CRYO1 CRYO-ABLATION PROBE
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GEH
2008-02-07
SANARUS V2 TREATMENT SYSTEM
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GEH
2007-12-10
ICE-SENSE
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GEH
2007-12-07
CRYOSPRAY ABLATION SYSTEM, MODEL CC2-NAM
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GEH
2007-12-03
CRY-AC TRACKER, MODEL(S) B-700T, AND B-800T
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GEH
2007-05-01
CRYOSPRAY ABLATION SYSTEM, MODEL CU 8407020500
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GEH
2007-03-20
ISIS
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GEH
2007-01-03
V2 TREATMENT SYSTEM (V2 CONSOLE, V2 ICE PROBE, V2 DEWARS) MODELS; VS3000, VP0600, VD0600
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GEH
2006-08-28
CRYOCARE CN2 SYSTEM
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GEH
2006-07-18
SANARUS VISICA TREATMENT SYSTEM
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GEH
2006-07-18
COMPOUND W FREEZE OFF WART REMOVAL SYSTEM
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GEH
2006-05-22
CRYOSHAPE
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GEH
2006-04-27
SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA
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GEH
2006-04-21
SPRAYGENIX CRYO ABLATION SYSTEM
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GEH
2006-02-28
CRYOCARE CS SURGICAL SYSTEM
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GEH
2006-02-13
SEEDNET/SEEDNETGOLD, CRYOTHERA AND CRYO-HIT SYSTEMS
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GEH
2005-12-14
DR. SCHOLL'S DUAL ACTION FREEZE AWAY WART REMOVER, MODEL 40406
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GEH
2005-11-18
SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA
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GEH
2005-11-15
MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM , MODELS VS2000
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GEH
2005-07-27
ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES
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GEH
2005-05-06
SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM)
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GEH
2005-02-25
MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM
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GEH
2004-10-14
SEEDNET GOLD WITH RENAL KIT, MODEL FPRPR 3021, (RENAL KIT), FPRCH 2024 (SEEDNETGOLD)
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GEH
2004-09-28
POLAR WAND
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GEH
2004-05-21
CRYMED CRYO-ABLATOR
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GEH
2003-09-10
WARTNER WART REMOVAL SYSTEM, MODEL 66715 82000 (PRODUCT CODE NUMBER 52E022)
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GEH
2003-08-29
DR. SCHOLL'S FREEZE AWAY WART REMOVER, MODEL 40226
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GEH
2003-08-12
CRYOCARE CS SURGICAL SYSTEM
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GEH
2003-06-27
WARTNER PRO
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GEH
2003-05-23
SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM
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GEH
2003-04-29
FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC CRYOABLATION CRYOCONSOLE
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GEH
2003-03-20
CRYOPROBE
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GEH
2003-03-20
HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME
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GEH
2002-12-05
CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20
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GEH
2002-10-15
SANARUS VISICA TREATMENT SYSTEM
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GEH
2002-07-31
POLAR WAND
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GEH
2002-07-03
SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM, MODELS GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3
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GEH
2002-06-26
MODIFICATION TO SANARUS VISICA TREATMENT SYSTEM
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GEH
2002-04-26
CRYOPEN AND ACCESSORIES
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GEH
2002-03-08
SANARUS VISICA TREATMENT SYSTEM
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GEH
2002-02-20
MODIFICATION TO WARTNER WART REMOVAL SYSTEM
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GEH
2002-01-29
SEEDNET, MODEL FP6T5, FP5T5, FP5T3
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GEH
2002-01-25
CRYOCARE SURGICAL SYSTEM
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GEH
2001-10-30
CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1
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GEH
2001-10-11
CRYOCARE SURGICAL SYSTEM
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GEH
2001-08-22
CRYOPLAN SYSTEM
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GEH
2001-05-03
SEEDNET, MODELS FP6T5, FP5T5, FP5T3
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GEH
2000-11-28
WARTNER WART REMOVAL SYSTEM
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GEH
2000-11-13
SURGICAL SYSTEM WITH CRYOGUIDE
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GEH
2000-10-31
SEEDNET, MODEL EP6T5, EP5E5
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GEH
2000-02-18
CRYO-HIT
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GEH
1999-08-12
CRYO-MONO CRYOGENIC SYSTEM, MODEL CRYO-MONO WITH TUF PROBE
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GEH
1999-07-27
CRYO-HIT II, MODELS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5
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GEH
1999-07-12
CRYO-HIT,MODELS ED1TO, EPITI, EP2TI, EP2T2, EP3T3, EP4T2, EPT3, EP4T4,EP5T2, EP5T3, EP5T5, EP6T5,EP7T3,EP7T5,EP8T3,AND E
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GEH
1999-07-01
CRYO-MONO CRYOGRNIC SYSTEM
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GEH
1999-06-14
HISTOFREEZER DEVICE
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GEH
1999-01-27
VERRUCA-FREEZE CRYOSURGERY DELIVERY SYSTEM
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GEH
1998-11-25
CRYOPRO MAXI AND CRYOPRO MINI
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GEH
1998-10-02
HISTOFREEZER DEVICE
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GEH
1998-09-08
ACCUPROBE 800 SERIES MODEL NUMBERS : 810, 820, 830, 840, 850, 860, 870 AND 880
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GEH
1998-07-17
CMS BLIZZARD 700 SERIES MODELS 710, 711, 712, 720, 721 AND 722
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GEH
1998-07-17
CMS BLIZZARD 700 SERIES MODELS 730, 740,750,760,770,780 & 790
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GEH
1998-05-26
HISTOFREEZER/ 17% SALICYLIC ACID-VERRUCA PLANTARIS
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GEH
1998-04-10
ENDOCRE CRYOCARE CRYOSURGICAL SYSTEM
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GEH
1997-12-22
ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM
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GEH
1997-10-21
HISTOFREEZER VERRUCA PLANA
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GEH
1997-10-01
CRYOGEN CRYOSURGICAL SYSTEM
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GEH
1997-07-07
CMS CRYOLITE
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GEH
1997-06-17
PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS
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GEH
1997-05-29
FRIGIDERM FRIGISPRAY
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GEH
1997-03-28
CRYOGEN CRYOSURGICAL SYSTEM
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GEH
1997-03-20
CMS ACCUPROBE 610, 620, 630, 640, 650, 660, 670, 680
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GEH
1997-03-19
CRYOSIL SILICONE GEL SHEETING
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GEH
1997-02-25
ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM URETHRAL WARMING SYSTEM
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GEH
1996-12-18
ENDOCARE CRYCARE CRYOSURGICAL SYSTEM
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GEH
1996-06-21
PERCUTANEOUS INTRODUCER SYSTEM
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GEH
1996-04-03
CANDELA HCS 2000 URETHERAL WARMER CATHETER
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GEH
1996-04-01
UROSPROBE SYSTEM, MODEL 1000
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GEH
1996-02-08
VERRUCA-FREEZE CRYOSURGICAL DELIVERY SYSTEM (MODIFICATION)
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GEH
1996-02-08
MEDI-FRIG
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GEH
1996-02-05
CANDELA CRYO-PROBE HOLDER
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GEH
1995-12-04
CMS ACCUPROBE 550/530
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GEH
1995-10-24
CMS URETHRAL WARMER
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GEH
1995-10-18
CANDELA CRYOSYSTEM CS-5
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