Atlas FDA

GEH

263 FDA 510(k) clearances · Product code

88 daysmedian time to decision
238 days90th percentile
263clearances measured

FDA profile

Official device name
Unit, Cryosurgical, Accessories
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4350
Medical specialty
General, Plastic Surgery
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 213 · 2022: 230 · 2023: 164 · 2024: 141 · 2025: 174 · 2026: 175
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000) (K261068)Serpex Medical2026-06-30
ERBECRYO 2 Cryosurgical Unit and Accessories (K261806)Erbe Elektromedizin GmbH2026-06-09
ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe (K253230)Erbe Elektromedizin GmbH2026-04-22
Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) (K252198)Medical Brands Laboratories B.V.2026-04-02
XSense Cryoablation System with CryoProbes (K260377)IceCure Medical , Ltd.2026-02-24
CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21) (K251928)Medinice S.A.2026-02-13
Dr. Yglo Skin Tag Remover (K251524)Theotclab Healthcare B.V.2026-01-12
Focused Cryotherapy System (K250742)Focused Cryo, Inc.2025-12-09
CryoFreeze Wart and Skin Tag Remover (K253000)Cryosurgery, Inc.2025-10-16
TargetCool™ (RM-DT02W) (K253114)Recensmedical, Inc.2025-10-16
TargetCool-e (K253348)Recensmedical, Inc.2025-10-15
Verruca-Freeze H Plus (K252903)Cryosurgery, Inc.2025-10-10
Skin Clinic Freeze Point for Warts and Skin Tags (K251493)Cryoconcepts LP2025-05-22
Skin Clinic Nitro Clear Wart Remover (K242932)Cryoconcepts LP2025-04-15
CryoFreeze Wart and Skin Tag Remover (K243487)Cryosurgery, Inc.2025-03-13
Co-Ablation System with Sterile Co-Ablation Probe (K243042)Hygea Medical Technology Co., Ltd.2025-01-29
Advanced Cryo Wart Remover (K242288)Medical Brands Laboratories B.V.2025-01-21
Verruca-Freeze H (K243454)Cryosurgery, Inc.2024-12-03
Compound W Skin Tag Remover (K242803)Medtech Products, Inc.2024-11-06
Freeze Point & Private Label Versions (K242625)Cryoconcepts LP2024-10-25
IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) (K243245)Boston Scientific Corp2024-10-18
Celsio Flexible Cryocatheter System (K240776)Endocision Technologies, Inc.2024-09-24
C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) (K240457)Pentax of America, Inc.2024-07-24
XSense Cryoablation System with Cryoprobes (K240892)IceCure Medical , Ltd.2024-06-28
Histofreezer V (K240106)Cryoconcepts LP2024-06-10
ICEfx Cryoablation System (FPRCH8000-02) (K234002)Boston Scientific2024-03-13
Verruca-Freeze® H (K233347)Cryosurgery, Inc.2023-12-04
CryoThin™ Surgical System and Accessories (K231661)Medinux (Tianjin) Technologies Co., Ltd.2023-11-27
IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100) (K232635)Boston Scientific2023-11-22
Visual-ICE Cryoablation System (K230551)Boston Scientific Corporation2023-08-08
TargetCool™ (K230599)Recensmedical, Inc.2023-06-22
Hydrozid Precise (K221897)Bibawo Medical A/S2023-05-30
Claritag Advanced (K222356)Dgi Technologies2023-05-18
ISOLIS Cryoprobe (K230271)Varian Medical Systems, Inc.2023-03-28
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 (K223369)STERIS Corporation2022-12-02
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 (K222272)STERIS Corporation2022-08-18
TargetCool (K221234)Recensmedical, Inc.2022-07-22
Freeze’n Clear Skin Clinic Warts & Tags (K211099)Cryoconcepts LP2022-06-17
TargetCool (K220674)Recensmedical, Inc.2022-03-31
Urethral Warming Catheter Kit (K211149)Varian Medical Systems, Inc.2022-01-05
C2 CryoBalloon Ablation System (K212814)Pentax of America, Inc.2021-11-29
CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit (K210310)Nuance Medical, LLC2021-10-22
Hydrozid (K201740)Medilink A/S2021-07-07
CryoVIVE (K203481)Recensmedical, Inc.2021-05-13
Dr. Yglo Wart Remover (K210529)Theotclab Healthcare B.V.2021-05-06
Forwarts (K201366)Pronova Laboratories BV2021-01-21
Vortex Radial Spray Catheter (K201183)CSA Medical, Inc.2020-12-07
C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge (K203024)Pentax of America, Inc.2020-11-24
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 (K203032)Galil Medical, Inc.2020-11-02
Dermal Cooling System (K201260)R2 Technologies, Inc.2020-09-24
CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice (K201588)Varian Medical Systems, Inc.2020-08-11
Frozen N (K193665)Yozma Bmtech Co., Ltd.2020-05-28
Cry-Ac®, Cry-Ac-3®, Cry-Baby (K193619)Brymill Cryogenic Systems2020-03-25
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 (K190651)Erbe Elektromedizin GmbH2020-01-07
IceSense 3, ProSense, MultiSense (K183213)IceCure Medical , Ltd.2019-12-20
Claritag (K190747)Dgi Technologies2019-10-31
C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge (K190194)Pentax Medical, A Division of Pentax of America, Inc.2019-05-31
CryoLab (K190407)Cryoconcepts LP2019-04-22
CryoTouch (K183601)Cryoconcepts LP2019-04-18
ClariFix (K190356)Arrinex, Inc.2019-02-26
Frozen C (K182392)B.M. Tech. Worldwide Co., Ltd.2018-10-30
IceSphere 1.5 CX Cryoablation Needle (K181741)Galil Medical , Ltd.2018-07-30
ICEfx Cryoablation System (K181153)Galil Medical, Inc.2018-05-15
Freezpoint (K180211)Bovie Medical Corp.2018-03-21
AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF) (K180137)AtriCure, Inc.2018-02-15
C2 CryoBalloon Ablation System (K163684)C2 Therapeutics, Inc.2018-01-23
CryOmega Flexx (K172769)Cryoconcepts LP2017-11-30
Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel (K173037)Galil Medical, Inc.2017-11-21
Compound W Nitro-Freeze (K172373)Medtech Products, Inc.2017-11-02
CRYOFOS (K170810)Cryofos Medical GmbH2017-09-27
truFreeze System (K171626)CSA Medical, Inc.2017-08-30
CryoIQ DERM, CryoIQ PRO, CryoIQ EquiMED (K172049)Cry IQ AB2017-08-30
truFreeze System (K172041)CSA Medical, Inc.2017-07-27
truFreeze Rapid AV Spray Kit (K171522)CSA Medical, Inc.2017-07-14
Dermal Cooling System (K171398)R2 Dermatology ,Inc2017-07-06
truFreeze System (K163244)CSA Medical, Inc.2017-05-24
ClariFix Device (K162608)Arrinex, Inc.2017-02-14
C2 Cryoballoon Ablation System (K161202)C2 Therapeutics, Inc.2017-01-05
truFreeze System (K162695)CSA Medical, Inc.2016-10-25
IcePearl 2.1 CX L, IceForce 2.1 CX L (K162599)Galil Medical , Ltd.2016-10-11
R2 Dermal Cooling System (K161480)R2 Dermatology2016-10-05
Compound W Wart Removal System Dual Power (K161294)Medtech Products, Inc.2016-09-15
Accurett (K161615)H&O Equipments, Nv/Sa2016-08-23
truFreeze System (K161557)CSA Medical, Inc.2016-07-26
CryoDose H or Similar (K161337)Nuance Medical, LLC2016-07-12
Cool Renewal (K161296)Cool Renewal, LLC2016-07-06
ClariFix Device (K160669)Arrinex, Inc.2016-06-24
C2 CryoBalloon Focal Pear Catheter (K160994)C2 Therapeutics, Inc.2016-05-19
Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System (K152329)C2 Therapeutics, Inc.2016-04-13
truFreeze System (K160273)Csa Medial, Inc.2016-03-25
cryoFORM cryoICE cryoablation probe (K152337)AtriCure, Inc.2016-03-22
Cryocare CS Surgical System (K153489)Healthtronics2016-02-05
Coldplay CryoBalloon® Ablation System (K153541)C2 Therapeutics, Inc.2016-01-07
UTERMOHLEN CRYO PROFESSIONAL (K152203)Koninklijke (Royal) Utermohlen2015-11-06
truFreeze System (K152668)CSA Medical, Inc.2015-10-14
Cryocare CS-3 Surgical System version 5 (K151968)Healthtronics2015-09-09
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 (K152133)Galil Medical , Ltd.2015-08-28
Wartie Advanced Wart Remover or other proprietary name (K151309)Youmedical Corp BV2015-08-14
Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System (K151054)C2 Therapeutics, Inc.2015-07-07
CRYOCARE CS SURGICAL SYSTEM (K141110)Healthtronics2015-06-25
Next →

Track GEH automatically

Every clearance here is in the API, with alerts when new ones post.