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 2026-09-02

Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)

Applicant Serpex Medical

K number K262420

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GEH 2026-06-30

Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)

Applicant Serpex Medical

K number K261068

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GEH 2026-06-09

ERBECRYO 2 Cryosurgical Unit and Accessories

Applicant Erbe Elektromedizin GmbH

K number K261806

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GEH 2026-04-22

ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe

Applicant Erbe Elektromedizin GmbH

K number K253230

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GEH 2026-04-02

Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)

Applicant Medical Brands Laboratories B.V.

K number K252198

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GEH 2026-02-24

XSense Cryoablation System with CryoProbes

Applicant IceCure Medical , Ltd.

K number K260377

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GEH 2026-02-13

CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)

Applicant Medinice S.A.

K number K251928

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GEH 2026-01-12

Dr. Yglo Skin Tag Remover

Applicant Theotclab Healthcare B.V.

K number K251524

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GEH 2025-12-09

Focused Cryotherapy System

Applicant Focused Cryo, Inc.

K number K250742

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GEH 2025-10-16

TargetCool™ (RM-DT02W)

Applicant Recensmedical, Inc.

K number K253114

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GEH 2025-10-16

CryoFreeze Wart and Skin Tag Remover

Applicant Cryosurgery, Inc.

K number K253000

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GEH 2025-10-15

TargetCool-e

Applicant Recensmedical, Inc.

K number K253348

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GEH 2025-10-10

Verruca-Freeze H Plus

Applicant Cryosurgery, Inc.

K number K252903

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GEH 2025-05-22

Skin Clinic Freeze Point for Warts and Skin Tags

Applicant Cryoconcepts LP

K number K251493

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GEH 2025-04-15

Skin Clinic Nitro Clear Wart Remover

Applicant Cryoconcepts LP

K number K242932

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GEH 2025-03-13

CryoFreeze Wart and Skin Tag Remover

Applicant Cryosurgery, Inc.

K number K243487

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GEH 2025-01-29

Co-Ablation System with Sterile Co-Ablation Probe

Applicant Hygea Medical Technology Co., Ltd.

K number K243042

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GEH 2025-01-21

Advanced Cryo Wart Remover

Applicant Medical Brands Laboratories B.V.

K number K242288

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GEH 2024-12-03

Verruca-Freeze H

Applicant Cryosurgery, Inc.

K number K243454

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GEH 2024-11-06

Compound W Skin Tag Remover

Applicant Medtech Products, Inc.

K number K242803

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GEH 2024-10-25

Freeze Point & Private Label Versions

Applicant Cryoconcepts LP

K number K242625

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GEH 2024-10-18

IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330)

Applicant Boston Scientific Corp

K number K243245

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GEH 2024-09-24

Celsio Flexible Cryocatheter System

Applicant Endocision Technologies, Inc.

K number K240776

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GEH 2024-07-24

C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)

Applicant Pentax of America, Inc.

K number K240457

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GEH 2024-06-28

XSense Cryoablation System with Cryoprobes

Applicant IceCure Medical , Ltd.

K number K240892

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GEH 2024-06-10

Histofreezer V

Applicant Cryoconcepts LP

K number K240106

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GEH 2024-03-13

ICEfx Cryoablation System (FPRCH8000-02)

Applicant Boston Scientific

K number K234002

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GEH 2023-12-04

Verruca-Freeze® H

Applicant Cryosurgery, Inc.

K number K233347

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GEH 2023-11-27

CryoThin™ Surgical System and Accessories

Applicant Medinux (Tianjin) Technologies Co., Ltd.

K number K231661

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GEH 2023-11-22

IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)

Applicant Boston Scientific

K number K232635

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GEH 2023-08-08

Visual-ICE Cryoablation System

Applicant Boston Scientific Corporation

K number K230551

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GEH 2023-06-22

TargetCool™

Applicant Recensmedical, Inc.

K number K230599

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GEH 2023-05-30

Hydrozid Precise

Applicant Bibawo Medical A/S

K number K221897

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GEH 2023-05-18

Claritag Advanced

Applicant Dgi Technologies

K number K222356

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GEH 2023-03-28

ISOLIS Cryoprobe

Applicant Varian Medical Systems, Inc.

K number K230271

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GEH 2022-12-02

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

Applicant STERIS Corporation

K number K223369

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GEH 2022-08-18

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

Applicant STERIS Corporation

K number K222272

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GEH 2022-07-22

TargetCool

Applicant Recensmedical, Inc.

K number K221234

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GEH 2022-06-17

Freeze’n Clear Skin Clinic Warts & Tags

Applicant Cryoconcepts LP

K number K211099

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GEH 2022-03-31

TargetCool

Applicant Recensmedical, Inc.

K number K220674

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GEH 2022-01-05

Urethral Warming Catheter Kit

Applicant Varian Medical Systems, Inc.

K number K211149

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GEH 2021-11-29

C2 CryoBalloon Ablation System

Applicant Pentax of America, Inc.

K number K212814

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GEH 2021-10-22

CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit

Applicant Nuance Medical, LLC

K number K210310

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GEH 2021-07-07

Hydrozid

Applicant Medilink A/S

K number K201740

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GEH 2021-05-13

CryoVIVE

Applicant Recensmedical, Inc.

K number K203481

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GEH 2021-05-06

Dr. Yglo Wart Remover

Applicant Theotclab Healthcare B.V.

K number K210529

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GEH 2021-01-21

Forwarts

Applicant Pronova Laboratories BV

K number K201366

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GEH 2020-12-07

Vortex Radial Spray Catheter

Applicant CSA Medical, Inc.

K number K201183

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GEH 2020-11-24

C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge

Applicant Pentax of America, Inc.

K number K203024

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GEH 2020-11-02

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

Applicant Galil Medical, Inc.

K number K203032

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GEH 2020-09-24

Dermal Cooling System

Applicant R2 Technologies, Inc.

K number K201260

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GEH 2020-08-11

CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice

Applicant Varian Medical Systems, Inc.

K number K201588

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GEH 2020-05-28

Frozen N

Applicant Yozma Bmtech Co., Ltd.

K number K193665

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GEH 2020-03-25

Cry-Ac®, Cry-Ac-3®, Cry-Baby

Applicant Brymill Cryogenic Systems

K number K193619

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GEH 2020-01-07

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

Applicant Erbe Elektromedizin GmbH

K number K190651

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GEH 2019-12-20

IceSense 3, ProSense, MultiSense

Applicant IceCure Medical , Ltd.

K number K183213

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GEH 2019-10-31

Claritag

Applicant Dgi Technologies

K number K190747

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GEH 2019-05-31

C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge

Applicant Pentax Medical, A Division of Pentax of America, Inc.

K number K190194

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GEH 2019-04-22

CryoLab

Applicant Cryoconcepts LP

K number K190407

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GEH 2019-04-18

CryoTouch

Applicant Cryoconcepts LP

K number K183601

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GEH 2019-02-26

ClariFix

Applicant Arrinex, Inc.

K number K190356

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GEH 2018-10-30

Frozen C

Applicant B.M. Tech. Worldwide Co., Ltd.

K number K182392

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GEH 2018-07-30

IceSphere 1.5 CX Cryoablation Needle

Applicant Galil Medical , Ltd.

K number K181741

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GEH 2018-05-15

ICEfx Cryoablation System

Applicant Galil Medical, Inc.

K number K181153

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GEH 2018-03-21

Freezpoint

Applicant Bovie Medical Corp.

K number K180211

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GEH 2018-02-15

AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF)

Applicant AtriCure, Inc.

K number K180137

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GEH 2018-01-23

C2 CryoBalloon Ablation System

Applicant C2 Therapeutics, Inc.

K number K163684

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GEH 2017-11-30

CryOmega Flexx

Applicant Cryoconcepts LP

K number K172769

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GEH 2017-11-21

Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel

Applicant Galil Medical, Inc.

K number K173037

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GEH 2017-11-02

Compound W Nitro-Freeze

Applicant Medtech Products, Inc.

K number K172373

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GEH 2017-09-27

CRYOFOS

Applicant Cryofos Medical GmbH

K number K170810

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GEH 2017-08-30

CryoIQ DERM, CryoIQ PRO, CryoIQ EquiMED

Applicant Cry IQ AB

K number K172049

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GEH 2017-08-30

truFreeze System

Applicant CSA Medical, Inc.

K number K171626

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GEH 2017-07-27

truFreeze System

Applicant CSA Medical, Inc.

K number K172041

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GEH 2017-07-14

truFreeze Rapid AV Spray Kit

Applicant CSA Medical, Inc.

K number K171522

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GEH 2017-07-06

Dermal Cooling System

Applicant R2 Dermatology ,Inc

K number K171398

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GEH 2017-05-24

truFreeze System

Applicant CSA Medical, Inc.

K number K163244

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GEH 2017-02-14

ClariFix Device

Applicant Arrinex, Inc.

K number K162608

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GEH 2017-01-05

C2 Cryoballoon Ablation System

Applicant C2 Therapeutics, Inc.

K number K161202

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GEH 2016-10-25

truFreeze System

Applicant CSA Medical, Inc.

K number K162695

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GEH 2016-10-11

IcePearl 2.1 CX L, IceForce 2.1 CX L

Applicant Galil Medical , Ltd.

K number K162599

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GEH 2016-10-05

R2 Dermal Cooling System

Applicant R2 Dermatology

K number K161480

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GEH 2016-09-15

Compound W Wart Removal System Dual Power

Applicant Medtech Products, Inc.

K number K161294

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GEH 2016-08-23

Accurett

Applicant H&O Equipments, Nv/Sa

K number K161615

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GEH 2016-07-26

truFreeze System

Applicant CSA Medical, Inc.

K number K161557

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GEH 2016-07-12

CryoDose H or Similar

Applicant Nuance Medical, LLC

K number K161337

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GEH 2016-07-06

Cool Renewal

Applicant Cool Renewal, LLC

K number K161296

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GEH 2016-06-24

ClariFix Device

Applicant Arrinex, Inc.

K number K160669

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GEH 2016-05-19

C2 CryoBalloon Focal Pear Catheter

Applicant C2 Therapeutics, Inc.

K number K160994

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GEH 2016-04-13

Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System

Applicant C2 Therapeutics, Inc.

K number K152329

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GEH 2016-03-25

truFreeze System

Applicant Csa Medial, Inc.

K number K160273

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GEH 2016-03-22

cryoFORM cryoICE cryoablation probe

Applicant AtriCure, Inc.

K number K152337

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GEH 2016-02-05

Cryocare CS Surgical System

Applicant Healthtronics

K number K153489

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GEH 2016-01-07

Coldplay CryoBalloon® Ablation System

Applicant C2 Therapeutics, Inc.

K number K153541

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GEH 2013-08-22

CRYOBALLOON FOCAL ABLATION SYSTEM

Applicant C2 Therapeutics

K number K131523

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GEH 2013-06-14

NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY

Applicant Nuance Medical, LLC

K number K130995

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GEH 2013-06-05

WART FREEZE

Applicant Koninklijke Utermohlen NV

K number K130599

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GEH 2013-02-06

VISUAL-ICE CRYOABLATION SYSTEM

Applicant Galil Medical, Inc.

K number K123865

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GEH 2012-08-28

ICEROD CX CRYOABLATION NEEDLE ICEROD CX CRYOABLATION NEEDLE MULTIPACK

Applicant Galil Medical , Ltd.

K number K121251

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GEH 2012-06-06

ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE)

Applicant AtriCure, Inc.

K number K121507

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