Product Code: GEH FDA class 2 21 CFR 878.4350

Unit, Cryosurgical, Accessories

General, Plastic Surgery

Cryosurgical Unit Accessories (product code GEH) are components and accessories used in conjunction with cryosurgical units, which apply extreme cold to destroy abnormal or diseased tissue in general and plastic surgery settings. This device is classified as an FDA Class 2 device, representing moderate risk, and requires premarket notification (510(k)) clearance before marketing. Regulated under 21 CFR 878.4350 within the General, Plastic Surgery specialty (SU), it is eligible for third-party review as part of the 510(k) process.

View on FDA

510(k)s

262

FEI Numbers

Registration Numbers

Unique Applicants

102

Years Active

Basic Information

Product Code: GEH
Device Class: FDA class 2
Regulation Number: 878.4350
Medical Specialty: General, Plastic Surgery
Review Panel: SU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 262 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K261806	ERBECRYO 2 Cryosurgical Unit and Accessories	Jun 09, 2026	Substantially Equivalent	Erbe Elektromedizin GmbH
K253230	ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe	Apr 22, 2026	Substantially Equivalent	Erbe Elektromedizin GmbH
K252198	Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)	Apr 02, 2026	Substantially Equivalent	Medical Brands Laboratories B.V.
K260377	XSense Cryoablation System with CryoProbes	Feb 24, 2026	Substantially Equivalent	IceCure Medical , Ltd.
K251928	CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)	Feb 13, 2026	Substantially Equivalent	Medinice S.A.
K251524	Dr. Yglo Skin Tag Remover	Jan 12, 2026	Substantially Equivalent	Theotclab Healthcare B.V.
K250742	Focused Cryotherapy System	Dec 09, 2025	Substantially Equivalent	Focused Cryo, Inc.
K253114	TargetCool (RM-DT02W)	Oct 16, 2025	Substantially Equivalent	Recensmedical, Inc.
K253000	CryoFreeze Wart and Skin Tag Remover	Oct 16, 2025	Substantially Equivalent	Cryosurgery, Inc.
K253348	TargetCool-e	Oct 15, 2025	Substantially Equivalent	Recensmedical, Inc.
K252903	Verruca-Freeze H Plus	Oct 10, 2025	Substantially Equivalent	Cryosurgery, Inc.
K251493	Skin Clinic Freeze Point for Warts and Skin Tags	May 22, 2025	Substantially Equivalent	Cryoconcepts LP
K242932	Skin Clinic Nitro Clear Wart Remover	Apr 15, 2025	Substantially Equivalent	Cryoconcepts LP
K243487	CryoFreeze Wart and Skin Tag Remover	Mar 13, 2025	Substantially Equivalent	Cryosurgery, Inc.
K243042	Co-Ablation System with Sterile Co-Ablation Probe	Jan 29, 2025	Substantially Equivalent	Hygea Medical Technology Co., Ltd.
K242288	Advanced Cryo Wart Remover	Jan 21, 2025	Substantially Equivalent	Medical Brands Laboratories B.V.
K243454	Verruca-Freeze H	Dec 03, 2024	Substantially Equivalent	Cryosurgery, Inc.
K242803	Compound W Skin Tag Remover	Nov 06, 2024	Substantially Equivalent	Medtech Products, Inc.
K242625	Freeze Point & Private Label Versions	Oct 25, 2024	Substantially Equivalent	Cryoconcepts LP
K243245	IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330)	Oct 18, 2024	Substantially Equivalent	Boston Scientific Corp
K240776	Celsio Flexible Cryocatheter System	Sep 24, 2024	Substantially Equivalent	Endocision Technologies, Inc.
K240457	C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)	Jul 24, 2024	Substantially Equivalent	Pentax of America, Inc.
K240892	XSense Cryoablation System with Cryoprobes	Jun 28, 2024	Substantially Equivalent	IceCure Medical , Ltd.
K240106	Histofreezer V	Jun 10, 2024	Substantially Equivalent	Cryoconcepts LP
K234002	ICEfx Cryoablation System (FPRCH8000-02)	Mar 13, 2024	Substantially Equivalent	Boston Scientific
K233347	Verruca-Freeze® H	Dec 04, 2023	Substantially Equivalent	Cryosurgery, Inc.
K231661	CryoThin Surgical System and Accessories	Nov 27, 2023	Substantially Equivalent	Medinux (Tianjin) Technologies Co., Ltd.
K232635	IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)	Nov 22, 2023	Substantially Equivalent	Boston Scientific
K230551	Visual-ICE Cryoablation System	Aug 08, 2023	Substantially Equivalent	Boston Scientific Corporation
K230599	TargetCool	Jun 22, 2023	Substantially Equivalent	Recensmedical, Inc.
K221897	Hydrozid Precise	May 30, 2023	Substantially Equivalent	Bibawo Medical A/S
K222356	Claritag Advanced	May 18, 2023	Substantially Equivalent	Dgi Technologies
K230271	ISOLIS Cryoprobe	Mar 28, 2023	Substantially Equivalent	Varian Medical Systems, Inc.
K223369	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 5 Pack, PN 2000184	Dec 02, 2022	Substantially Equivalent	STERIS Corporation
K222272	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 5 Pack, PN 2000184	Aug 18, 2022	Substantially Equivalent	STERIS Corporation
K221234	TargetCool	Jul 22, 2022	Substantially Equivalent	Recensmedical, Inc.
K211099	Freezen Clear Skin Clinic Warts & Tags	Jun 17, 2022	Substantially Equivalent	Cryoconcepts LP
K220674	TargetCool	Mar 31, 2022	Substantially Equivalent	Recensmedical, Inc.
K211149	Urethral Warming Catheter Kit	Jan 05, 2022	Substantially Equivalent	Varian Medical Systems, Inc.
K212814	C2 CryoBalloon Ablation System	Nov 29, 2021	Substantially Equivalent	Pentax of America, Inc.
K210310	CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit	Oct 22, 2021	Substantially Equivalent	Nuance Medical, LLC
K201740	Hydrozid	Jul 07, 2021	Substantially Equivalent	Medilink A/S
K203481	CryoVIVE	May 13, 2021	Substantially Equivalent	Recensmedical, Inc.
K210529	Dr. Yglo Wart Remover	May 06, 2021	Substantially Equivalent	Theotclab Healthcare B.V.
K201366	Forwarts	Jan 21, 2021	Substantially Equivalent	Pronova Laboratories BV
K201183	Vortex Radial Spray Catheter	Dec 07, 2020	Substantially Equivalent	CSA Medical, Inc.
K203024	C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge	Nov 24, 2020	Substantially Equivalent	Pentax of America, Inc.
K203032	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	Nov 02, 2020	Substantially Equivalent	Galil Medical, Inc.
K201260	Dermal Cooling System	Sep 24, 2020	Substantially Equivalent	R2 Technologies, Inc.
K201588	CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice	Aug 11, 2020	Substantially Equivalent	Varian Medical Systems, Inc.
K193665	Frozen N	May 28, 2020	Substantially Equivalent	Yozma Bmtech Co., Ltd.
K193619	Cry-Ac®, Cry-Ac-3®, Cry-Baby	Mar 25, 2020	Substantially Equivalent	Brymill Cryogenic Systems
K190651	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	Jan 07, 2020	Substantially Equivalent	Erbe Elektromedizin GmbH
K183213	IceSense 3, ProSense, MultiSense	Dec 20, 2019	Substantially Equivalent	IceCure Medical , Ltd.
K190747	Claritag	Oct 31, 2019	Substantially Equivalent	Dgi Technologies
K190194	C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge	May 31, 2019	Substantially Equivalent	Pentax Medical, A Division of Pentax of America, Inc.
K190407	CryoLab	Apr 22, 2019	Substantially Equivalent	Cryoconcepts LP
K183601	CryoTouch	Apr 18, 2019	Substantially Equivalent	Cryoconcepts LP
K190356	ClariFix	Feb 26, 2019	Substantially Equivalent	Arrinex, Inc.
K182392	Frozen C	Oct 30, 2018	Substantially Equivalent	B.M. Tech. Worldwide Co., Ltd.
K181741	IceSphere 1.5 CX Cryoablation Needle	Jul 30, 2018	Substantially Equivalent	Galil Medical , Ltd.
K181153	ICEfx Cryoablation System	May 15, 2018	Substantially Equivalent	Galil Medical, Inc.
K180211	Freezpoint	Mar 21, 2018	Substantially Equivalent	Bovie Medical Corp.
K180137	AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF)	Feb 15, 2018	Substantially Equivalent	AtriCure, Inc.
K163684	C2 CryoBalloon Ablation System	Jan 23, 2018	Substantially Equivalent	C2 Therapeutics, Inc.
K172769	CryOmega Flexx	Nov 30, 2017	Substantially Equivalent	Cryoconcepts LP
K173037	Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel	Nov 21, 2017	Substantially Equivalent	Galil Medical, Inc.
K172373	Compound W Nitro-Freeze	Nov 02, 2017	Substantially Equivalent	Medtech Products, Inc.
K170810	CRYOFOS	Sep 27, 2017	Substantially Equivalent	Cryofos Medical GmbH
K172049	CryoIQ DERM, CryoIQ PRO, CryoIQ EquiMED	Aug 30, 2017	Substantially Equivalent	Cry IQ AB
K171626	truFreeze System	Aug 30, 2017	Substantially Equivalent	CSA Medical, Inc.
K172041	truFreeze System	Jul 27, 2017	Substantially Equivalent	CSA Medical, Inc.
K171522	truFreeze Rapid AV Spray Kit	Jul 14, 2017	Substantially Equivalent	CSA Medical, Inc.
K171398	Dermal Cooling System	Jul 06, 2017	Substantially Equivalent	R2 Dermatology ,Inc
K163244	truFreeze System	May 24, 2017	Substantially Equivalent	CSA Medical, Inc.
K162608	ClariFix Device	Feb 14, 2017	Substantially Equivalent	Arrinex, Inc.
K161202	C2 Cryoballoon Ablation System	Jan 05, 2017	Substantially Equivalent	C2 Therapeutics, Inc.
K162695	truFreeze System	Oct 25, 2016	Substantially Equivalent	CSA Medical, Inc.
K162599	IcePearl 2.1 CX L, IceForce 2.1 CX L	Oct 11, 2016	Substantially Equivalent	Galil Medical , Ltd.
K161480	R2 Dermal Cooling System	Oct 05, 2016	Substantially Equivalent	R2 Dermatology
K161294	Compound W Wart Removal System Dual Power	Sep 15, 2016	Substantially Equivalent	Medtech Products, Inc.
K161615	Accurett	Aug 23, 2016	Substantially Equivalent	H&O Equipments, Nv/Sa
K161557	truFreeze System	Jul 26, 2016	Substantially Equivalent	CSA Medical, Inc.
K161337	CryoDose H or Similar	Jul 12, 2016	Substantially Equivalent	Nuance Medical, LLC
K161296	Cool Renewal	Jul 06, 2016	Substantially Equivalent	Cool Renewal, LLC
K160669	ClariFix Device	Jun 24, 2016	Substantially Equivalent	Arrinex, Inc.
K160994	C2 CryoBalloon Focal Pear Catheter	May 19, 2016	Substantially Equivalent	C2 Therapeutics, Inc.
K152329	Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System	Apr 13, 2016	Substantially Equivalent	C2 Therapeutics, Inc.
K160273	truFreeze System	Mar 25, 2016	Substantially Equivalent	Csa Medial, Inc.
K152337	cryoFORM cryoICE cryoablation probe	Mar 22, 2016	Substantially Equivalent	AtriCure, Inc.
K153489	Cryocare CS Surgical System	Feb 05, 2016	Substantially Equivalent	Healthtronics
K153541	Coldplay CryoBalloon® Ablation System	Jan 07, 2016	Substantially Equivalent	C2 Therapeutics, Inc.
K152203	UTERMOHLEN CRYO PROFESSIONAL	Nov 06, 2015	Substantially Equivalent	Koninklijke (Royal) Utermohlen
K152668	truFreeze System	Oct 14, 2015	Substantially Equivalent	CSA Medical, Inc.
K151968	Cryocare CS-3 Surgical System version 5	Sep 09, 2015	Substantially Equivalent	Healthtronics
K152133	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	Aug 28, 2015	Substantially Equivalent	Galil Medical , Ltd.
K151309	Wartie Advanced Wart Remover or other proprietary name	Aug 14, 2015	Substantially Equivalent	Youmedical Corp BV
K151054	Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System	Jul 07, 2015	Substantially Equivalent	C2 Therapeutics, Inc.
K141110	CRYOCARE CS SURGICAL SYSTEM	Jun 25, 2015	Substantially Equivalent	Healthtronics
K150920	truFreeze System	Jun 17, 2015	Substantially Equivalent	CSA Medical, Inc.
K151041	ERBECRYO 2 Cryosurgical Unit with accessories	May 04, 2015	Substantially Equivalent	Erbe USA, Inc.
K143564	Visual-ICE Cryoablation System, Software Revision 1.3.1	Mar 05, 2015	Substantially Equivalent	Galil Medical, Inc.
K143625	truFreeze System	Jan 15, 2015	Substantially Equivalent	CSA Medical, Inc.
K142441	cryoICE croablation probe	Oct 29, 2014	Substantially Equivalent	AtriCure, Inc.
K141485	ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLE	Jul 02, 2014	Substantially Equivalent	Galil Medical , Ltd.
K133258	TRUFREEZE SYSTEM	Jun 19, 2014	Substantially Equivalent	CSA Medical, Inc.
K140314	WARTIE WART REMOVER	Jun 12, 2014	Substantially Equivalent	Yonmedical BV
K140584	ICEROD CX CRYOABLATION NEEDLE	Mar 31, 2014	Substantially Equivalent	Galil Medical , Ltd.
K140058	ATRICURE CRYO MODULE SYSTEM	Jan 24, 2014	Substantially Equivalent	AtriCure, Inc.
K131523	CRYOBALLOON FOCAL ABLATION SYSTEM	Aug 22, 2013	Substantially Equivalent	C2 Therapeutics
K130995	NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY	Jun 14, 2013	Substantially Equivalent	Nuance Medical, LLC
K130599	WART FREEZE	Jun 05, 2013	Substantially Equivalent	Koninklijke Utermohlen NV
K123865	VISUAL-ICE CRYOABLATION SYSTEM	Feb 06, 2013	Substantially Equivalent	Galil Medical, Inc.
K121251	ICEROD CX CRYOABLATION NEEDLE ICEROD CX CRYOABLATION NEEDLE MULTIPACK	Aug 28, 2012	Substantially Equivalent	Galil Medical , Ltd.
K121507	ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE)	Jun 06, 2012	Substantially Equivalent	AtriCure, Inc.
K113860	VISUAL-ICE CRYOABLATION SYSTEM	Mar 12, 2012	Substantially Equivalent	Galil Medical, Inc.
K113021	TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT	Feb 07, 2012	Substantially Equivalent	CSA Medical, Inc.
K111859	ICEEDGE 2.4 CRYOABLATION NEEDLE,ICEEDGE 2.4 CRYOABLATION NEEDLE MULTIPACK	Oct 07, 2011	Substantially Equivalent	Galil Medical, Inc.
K110754	CRYOPEN CRYOSURGICAL SYSTEM, K102214	Sep 09, 2011	Substantially Equivalent	Cryopen, Inc.
K112072	ATRICURE CRYO MODULE SYSTEM	Aug 03, 2011	Substantially Equivalent	AtriCure, Inc.
K101049	WART FREEZE	Jun 23, 2011	Substantially Equivalent	Koninklijke Utermohlen NV
K110946	ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE	Jun 21, 2011	Substantially Equivalent	Galil Medical , Ltd.
K111042	ATRICURE CRYO MODULE	May 26, 2011	Substantially Equivalent	AtriCure, Inc.
K103310	CRYONIZE TM	Feb 09, 2011	Substantially Equivalent	3jt Enterprises, LLC
K102360	ICESENCE 3	Nov 29, 2010	Substantially Equivalent	IceCure Medical , Ltd.
K102006	CRYOMEGA	Oct 06, 2010	Substantially Equivalent	Stc Consulting, LLC
K101825	CRYOBALLOON ABLATION SYSTEM	Sep 29, 2010	Substantially Equivalent	C2 Therapeutics
K101333	CRYOCARE CS SURGICAL SYSTEM	Jun 14, 2010	Substantially Equivalent	Endocare, Inc.
K091721	CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23	Oct 02, 2009	Substantially Equivalent	New Medical Technologies GmbH
K090978	UC-CARE WARMING SYSTEM	Aug 10, 2009	Substantially Equivalent	UC-CARE , Ltd.
K083493	MYOSCIENCE CRYO-TOUCH	Mar 20, 2009	Substantially Equivalent	Myoscience, Inc.
K082074	ATRICURE CRYO1 CRYO-ABLATION PROBE	Mar 02, 2009	Substantially Equivalent	AtriCure, Inc.
K073533	SANARUS V2 TREATMENT SYSTEM	Feb 07, 2008	Substantially Equivalent	Sanarus Medical, Inc.
K072883	ICE-SENSE	Dec 10, 2007	Substantially Equivalent	Arbel Medical , Ltd.
K072651	CRYOSPRAY ABLATION SYSTEM, MODEL CC2-NAM	Dec 07, 2007	Substantially Equivalent	CSA Medical, Inc.
K072453	CRY-AC TRACKER, MODEL(S) B-700T, AND B-800T	Dec 03, 2007	Substantially Equivalent	Brymill Corp.
K070893	CRYOSPRAY ABLATION SYSTEM, MODEL CU 8407020500	May 01, 2007	Substantially Equivalent	CSA Medical, Inc.
K070482	ISIS	Mar 20, 2007	Substantially Equivalent	Galil Medical , Ltd.
K062896	V2 TREATMENT SYSTEM (V2 CONSOLE, V2 ICE PROBE, V2 DEWARS) MODELS; VS3000, VP0600, VD0600	Jan 03, 2007	Substantially Equivalent	Sanarus Medical, Inc.
K062175	CRYOCARE CN2 SYSTEM	Aug 28, 2006	Substantially Equivalent	Endocare, Inc.
K061510	SANARUS VISICA TREATMENT SYSTEM	Jul 18, 2006	Substantially Equivalent	Sanarus Medical, Inc.
K060859	COMPOUND W FREEZE OFF WART REMOVAL SYSTEM	Jul 18, 2006	Substantially Equivalent	OraSure Technologies, Inc.
K060928	CRYOSHAPE	May 22, 2006	Substantially Equivalent	Etgar Group H.M.Y.A. , Ltd.
K060390	SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA	Apr 27, 2006	Substantially Equivalent	Galil Medical , Ltd.
K060555	SPRAYGENIX CRYO ABLATION SYSTEM	Apr 21, 2006	Substantially Equivalent	Crymed Technologies, Inc.
K060279	CRYOCARE CS SURGICAL SYSTEM	Feb 28, 2006	Substantially Equivalent	Endocare, Inc.
K060144	SEEDNET/SEEDNETGOLD, CRYOTHERA AND CRYO-HIT SYSTEMS	Feb 13, 2006	Substantially Equivalent	Galil Medical , Ltd.
K052259	DR. SCHOLL'S DUAL ACTION FREEZE AWAY WART REMOVER, MODEL 40406	Dec 14, 2005	Substantially Equivalent	Schering-Plough Healthcare Products, Inc.
K052530	SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA	Nov 18, 2005	Substantially Equivalent	Galil Medical , Ltd.
K052861	MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM , MODELS VS2000	Nov 15, 2005	Substantially Equivalent	Sanarus Medical, Inc.
K051509	ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES	Jul 27, 2005	Substantially Equivalent	Erbe USA, Inc.
K051052	SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM)	May 06, 2005	Substantially Equivalent	Galil Medical , Ltd.
K050347	MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM	Feb 25, 2005	Substantially Equivalent	Endocare, Inc.
K042667	SEEDNET GOLD WITH RENAL KIT, MODEL FPRPR 3021, (RENAL KIT), FPRCH 2024 (SEEDNETGOLD)	Oct 14, 2004	Substantially Equivalent	Galil Medical , Ltd.
K041783	POLAR WAND	Sep 28, 2004	Substantially Equivalent	Chek-Med Systems
K040809	CRYMED CRYO-ABLATOR	May 21, 2004	Substantially Equivalent	Crymed Technologies, Inc.
K032271	WARTNER WART REMOVAL SYSTEM, MODEL 66715 82000 (PRODUCT CODE NUMBER 52E022)	Sep 10, 2003	Substantially Equivalent	Wartner USA B.V.
K031697	DR. SCHOLL'S FREEZE AWAY WART REMOVER, MODEL 40226	Aug 29, 2003	Substantially Equivalent	Schering-Plough Healthcare Products, Inc.
K032333	CRYOCARE CS SURGICAL SYSTEM	Aug 12, 2003	Substantially Equivalent	Endocare, Inc.
K030838	WARTNER PRO	Jun 27, 2003	Substantially Equivalent	Wartner Medical Products
K031117	SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM	May 23, 2003	Substantially Equivalent	Galil Medical , Ltd.
K030303	FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC CRYOABLATION CRYOCONSOLE	Apr 29, 2003	Substantially Equivalent	Cryocath Technologies, Inc.
K024009	CRYOPROBE	Mar 20, 2003	Substantially Equivalent	H&O Equipments, Nv/Sa
K023487	HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME	Mar 20, 2003	Substantially Equivalent	OraSure Technologies, Inc.
K023757	CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20	Dec 05, 2002	Substantially Equivalent	Endocare, Inc.
K022314	SANARUS VISICA TREATMENT SYSTEM	Oct 15, 2002	Substantially Equivalent	Sanarus Medical, Inc.
K021387	POLAR WAND	Jul 31, 2002	Substantially Equivalent	Chek-Med Systems
K021261	SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM, MODELS GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3	Jul 03, 2002	Substantially Equivalent	Galil Medical , Ltd.
K021211	MODIFICATION TO SANARUS VISICA TREATMENT SYSTEM	Jun 26, 2002	Substantially Equivalent	Sanarus Medical, Inc.
K012214	CRYOPEN AND ACCESSORIES	Apr 26, 2002	Substantially Equivalent	Cimex Biotech, LLC
K020605	SANARUS VISICA TREATMENT SYSTEM	Mar 08, 2002	Substantially Equivalent	Sanarus Medical, Inc.
K011708	MODIFICATION TO WARTNER WART REMOVAL SYSTEM	Feb 20, 2002	Substantially Equivalent	Wartner Medical Products
K011950	SEEDNET, MODEL FP6T5, FP5T5, FP5T3	Jan 29, 2002	Substantially Equivalent	Galil Medical , Ltd.
K011074	CRYOCARE SURGICAL SYSTEM	Jan 25, 2002	Substantially Equivalent	Endocare, Inc.
K012497	CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1	Oct 30, 2001	Substantially Equivalent	Galil Medical , Ltd.
K003811	CRYOCARE SURGICAL SYSTEM	Oct 11, 2001	Substantially Equivalent	Endocare, Inc.
K011073	CRYOPLAN SYSTEM	Aug 22, 2001	Substantially Equivalent	Cryomedical Sciences, Inc.
K010991	SEEDNET, MODELS FP6T5, FP5T5, FP5T3	May 03, 2001	Substantially Equivalent	Galil Medical , Ltd.
K002714	WARTNER WART REMOVAL SYSTEM	Nov 28, 2000	Substantially Equivalent	Wartner Medical Products
K002615	SURGICAL SYSTEM WITH CRYOGUIDE	Nov 13, 2000	Substantially Equivalent	Endocare, Inc.
K003065	SEEDNET, MODEL EP6T5, EP5E5	Oct 31, 2000	Substantially Equivalent	Galil Medical , Ltd.
K993965	CRYO-HIT	Feb 18, 2000	Substantially Equivalent	Galil Medical , Ltd.
K991792	CRYO-MONO CRYOGENIC SYSTEM, MODEL CRYO-MONO WITH TUF PROBE	Aug 12, 1999	Substantially Equivalent	Influence, Inc.
K991517	CRYO-HIT II, MODELS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5	Jul 27, 1999	Substantially Equivalent	Galil Medical , Ltd.
K991272	CRYO-HIT,MODELS ED1TO, EPITI, EP2TI, EP2T2, EP3T3, EP4T2, EPT3, EP4T4,EP5T2, EP5T3, EP5T5, EP6T5,EP7T3,EP7T5,EP8T3,AND E	Jul 12, 1999	Substantially Equivalent	Galil Medical , Ltd.
K991122	CRYO-MONO CRYOGRNIC SYSTEM	Jul 01, 1999	Substantially Equivalent	Influence, Inc.
K990877	HISTOFREEZER DEVICE	Jun 14, 1999	Substantially Equivalent	OraSure Technologies, Inc.
K982506	VERRUCA-FREEZE CRYOSURGERY DELIVERY SYSTEM	Jan 27, 1999	Substantially Equivalent	Cryosurgery, Inc.
K982280	CRYOPRO MAXI AND CRYOPRO MINI	Nov 25, 1998	Substantially Equivalent	Cortex Technology Aps
K982358	HISTOFREEZER DEVICE	Oct 02, 1998	Substantially Equivalent	OraSure Technologies, Inc.
K982055	ACCUPROBE 800 SERIES MODEL NUMBERS : 810, 820, 830, 840, 850, 860, 870 AND 880	Sep 08, 1998	Substantially Equivalent	Cryomedical Sciences, Inc.
K980670	CMS BLIZZARD 700 SERIES MODELS 710, 711, 712, 720, 721 AND 722	Jul 17, 1998	Substantially Equivalent	Cryomedical Sciences, Inc.
K980668	CMS BLIZZARD 700 SERIES MODELS 730, 740,750,760,770,780 & 790	Jul 17, 1998	Substantially Equivalent	Cryomedical Sciences, Inc.
K980739	HISTOFREEZER/ 17% SALICYLIC ACID-VERRUCA PLANTARIS	May 26, 1998	Substantially Equivalent	OraSure Technologies, Inc.
K980110	ENDOCRE CRYOCARE CRYOSURGICAL SYSTEM	Apr 10, 1998	Substantially Equivalent	Endocare, Inc.
K973686	ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM	Dec 22, 1997	Substantially Equivalent	Endocare, Inc.
K971392	HISTOFREEZER VERRUCA PLANA	Oct 21, 1997	Substantially Equivalent	OraSure Technologies, Inc.
K972662	CRYOGEN CRYOSURGICAL SYSTEM	Oct 01, 1997	Substantially Equivalent	Cryogen, Inc.
K970995	CMS CRYOLITE	Jul 07, 1997	Substantially Equivalent	Cryomedical Sciences, Inc.
K970992	PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS	Jun 17, 1997	Substantially Equivalent	Premier Dental Products Co.
K971216	FRIGIDERM FRIGISPRAY	May 29, 1997	Substantially Equivalent	Dermatologic Lab & Supply, Inc.
K964971	CRYOGEN CRYOSURGICAL SYSTEM	Mar 28, 1997	Substantially Equivalent	Cryogen, Inc.
K964336	CMS ACCUPROBE 610, 620, 630, 640, 650, 660, 670, 680	Mar 20, 1997	Substantially Equivalent	Cryomedical Sciences, Inc.
K964047	CRYOSIL SILICONE GEL SHEETING	Mar 19, 1997	Substantially Equivalent	Biodermis Corp.
K963970	ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM URETHRAL WARMING SYSTEM	Feb 25, 1997	Substantially Equivalent	Endocare, Inc.
K963826	ENDOCARE CRYCARE CRYOSURGICAL SYSTEM	Dec 18, 1996	Substantially Equivalent	Endocare, Inc.
K961219	PERCUTANEOUS INTRODUCER SYSTEM	Jun 21, 1996	Substantially Equivalent	Boston Scientific Corp
K955011	CANDELA HCS 2000 URETHERAL WARMER CATHETER	Apr 03, 1996	Substantially Equivalent	Candela Laser Corp.
K960387	UROSPROBE SYSTEM, MODEL 1000	Apr 01, 1996	Substantially Equivalent	Uros Corp.
K955083	VERRUCA-FREEZE CRYOSURGICAL DELIVERY SYSTEM (MODIFICATION)	Feb 08, 1996	Substantially Equivalent	Cryosurgery, Inc.
K954703	MEDI-FRIG	Feb 08, 1996	Substantially Equivalent	Ellman Intl., Inc.
K954872	CANDELA CRYO-PROBE HOLDER	Feb 05, 1996	Substantially Equivalent	Candela Laser Corp.
K953637	CMS ACCUPROBE 550/530	Dec 04, 1995	Substantially Equivalent	Cryomedical Sciences, Inc.
K952895	CMS URETHRAL WARMER	Oct 24, 1995	Substantially Equivalent	Cryomedical Sciences, Inc.
K953294	CANDELA CRYOSYSTEM CS-5	Oct 18, 1995	Substantially Equivalent	Candela Laser Corp.
K942299	ENDOCARE CRYOTHERAPY SYSTEM	Jan 19, 1995	Substantially Equivalent	Cytocare, Inc.
K944221	VERRUCA-FREEZE(TM) CRYOSURGICAL DELIVERY SYST, MODIFIED	Dec 15, 1994	Substantially Equivalent	Cryosurgery, Inc.
K940140	HM-CRYO	Jun 27, 1994	Substantially Equivalent	Hill-Med, Inc.
K934261	ERBOKRYO CA CRYOSURGICAL SYSTEM	Apr 26, 1994	Substantially Equivalent	Erbe Elektromedizin GmbH
K912529	ERGOMED	Apr 26, 1994	Substantially Equivalent	Kryoderm USA, Inc.
K935010	WALLACH ULTRA FREEZE	Feb 09, 1994	Substantially Equivalent	Wallach Surgical Devices, Inc.
K933327	HISTOFREEZER	Oct 29, 1993	Substantially Equivalent	Solarcare, Inc.
K926464	L.C.S.3000	Aug 24, 1993	Substantially Equivalent	Cryodyne Technologies, Inc.
K931299	HISTOFREEZER	Aug 11, 1993	Substantially Equivalent	Solarcare Technologies Corp,Inc.
K924114	HISTOFREEZER	Feb 05, 1993	Substantially Equivalent	Solarcare Technologies Corp,Inc.
K922878	MODEL GT1ST CRYOSURGICAL INSTRUMENT	Sep 02, 1992	Substantially Equivalent	Gyne-Tech Instrument Corp.
K914591	L.C.S. 2000 SYSTEM	Jan 14, 1992	Substantially Equivalent	Stiefel Research Institute, Inc.
K911420	HISTOFREEZER	Jun 28, 1991	Substantially Equivalent	Solarcare Technologies Corp,Inc.
K910491	WALLACH COLD SOAKER	May 21, 1991	Substantially Equivalent	Wallach Surgical Devices, Inc.
K904421	CMS ONCOPROBE (TM)	Apr 08, 1991	Substantially Equivalent	Cryomedical Sciences, Inc.
K896724	CRYOJET LIQUID NITROGEN SPRAY CRYOSURGICAL INSTRU.	Jan 09, 1990	Substantially Equivalent	Stiefel Research Institute, Inc.
K892237	THE FERN CRYOPROBE	Jul 25, 1989	Substantially Equivalent	Cryogenic Instruments & Equipment , Ltd.
K891282	MIC-100 WITH CRYOPROBES	Jun 15, 1989	Substantially Equivalent	Frigitronics of Connecticut, Inc.
K882568	130 CRYO UNIT & ASSOC. CRYOPROBES & SPRAY	Sep 27, 1988	Substantially Equivalent	Spembly Medical , Ltd.
K880416	WCCS 800 WALLACH CARDIAC CRYOSURGICAL SYSTEM	Sep 26, 1988	Substantially Equivalent	Wallach Surgical Devices, Inc.
K882963	SPEMBLY MEDICAL 142 CRYO UNIT	Aug 08, 1988	Substantially Equivalent	Spembly Medical , Ltd.
K882962	SERIES 40 & SERIES 42 CRYOPROBES (R SERIES)	Aug 08, 1988	Substantially Equivalent	Spembly Medical , Ltd.
K881349	VERRUCA-FREEZE(TM) CRYOTHERAPY DELIVERY SYSTEM	Jun 30, 1988	Substantially Equivalent	Cryosurg, Inc.
K872796	ADDITIONS TO WSL NITROSPRAY CRYOSURGICAL UNITS	Jul 23, 1987	Substantially Equivalent	Tower Mfg. Co., Inc.
K871314	CRYOSURGICAL PROBE	Apr 28, 1987	Substantially Equivalent	Western Medical Research
K854767	LM 1000	Jan 24, 1986	Substantially Equivalent	Leisegang Medical, Inc.
K844246	NETHERY EXTREMITY FREEZING UNIT	Feb 28, 1985	Substantially Equivalent	Howard J. Nethery & Assoc.
K842959	MC-4000 CONSOLE & PROBES	Dec 07, 1984	Substantially Equivalent	Cryomedics, Inc.
K842704	MT-700 MT-750 FT-350	Aug 01, 1984	Substantially Equivalent	Cryomedics, Inc.
K840536	CRYO SURG 5900	Apr 23, 1984	Substantially Equivalent	Frigitronics of Connecticut, Inc.
K832385	CRYOPROBES MC-1400-CRYOSURG-CONSOLE	Sep 12, 1983	Substantially Equivalent	Spembly Medical , Ltd.
K832334	CRYOMEDICS 5000 CRYOSURGICAL CONSOLE	Aug 12, 1983	Substantially Equivalent	Spembly Medical , Ltd.
K832140	CRYOMEDICS 5000 CRYOPROBES	Aug 12, 1983	Substantially Equivalent	Spembly Medical , Ltd.
K813024	WA1000	Dec 03, 1981	Substantially Equivalent	Wallach Surgical Devices, Inc.
K811390	CCS100 CRYOSURGICAL SYSTEM	Jun 16, 1981	Substantially Equivalent	Frigitronics of Connecticut, Inc.
K810409	MODEL C2100-SERIES OPHTHALMIC CRYOPROBE	Mar 20, 1981	Substantially Equivalent	Valleylab, Inc.
K803311	LL100 CRYOSURGICAL SYSTEM	Feb 04, 1981	Substantially Equivalent	Wallach Surgical Devices, Inc.
K801921	GCS-79	Oct 31, 1980	Substantially Equivalent	Gilmore Liquid Air Co.
K800335	KRYMED LIQUID NITROGEN CRYOJET	Apr 04, 1980	Substantially Equivalent	Cryomedics, Inc.
K781956	CRYOSURGICAL DEVICE 2000	Jan 10, 1979	Substantially Equivalent	Valleylab, Inc.
K772232	LIQUID NITROGEN SPRAY UNIT	Dec 15, 1977	Substantially Equivalent	Gilmore Liquid Air Co.
K771320	CRYOSURGICAL EQUIPMENT	Dec 06, 1977	Substantially Equivalent	A.S.M.O.T.
K770058	PROBE, VACUUM INSULATED, SERIES 30	Feb 17, 1977	Substantially Equivalent	Spembly Medical , Ltd.
K760953	DEEP FREEZE SYSTEM (DFS-30)	Nov 16, 1976	Substantially Equivalent	Spembly Medical , Ltd.
K760742	CS-76 AND/OR CRYOCARE I	Nov 03, 1976	Substantially Equivalent	Frigitronics of Connecticut, Inc.
K760686	CRYOLYZER ALPHA (CRYOSURG.EQUIP.)	Nov 01, 1976	Substantially Equivalent	Cryo-Labs, Inc.
K760353	CRYOLYZER ALPHA	Oct 29, 1976	Substantially Equivalent	Pilling Co.