ClearanceBrief
Panels › General, Plastic Surgery › Product code GEH · Class 2

Unit, Cryosurgical, Accessories

Regulation 878.4350

9510(k)s in 12 months (264 all time)
5recalls in 12 months (107 all time)
87recalls that name a 510(k)
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Top companies in GEH

Company510(k)sRecalls
Boston Scientific553
Galil Medical , Ltd.297
CSA Medical, Inc.142
Endocare, Inc.131
Cooper Surgical, Inc.013
AtriCure, Inc.83
C2 Therapeutics81
Cryomedical Sciences, Inc.90
OraSure Technologies, Inc.63
Cryoconcepts LP80
Decided510(k)Device and applicantCode
Sep 2, 2026K262420Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)
Serpex Medical
GEH
Jun 30, 2026K261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)
Serpex Medical
GEH
Jun 9, 2026K261806ERBECRYO 2 Cryosurgical Unit and Accessories
Erbe Elektromedizin GmbH, DE
GEH
Apr 22, 2026K253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe
Erbe Elektromedizin GmbH, DE
GEH
Apr 2, 2026K252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)
Medical Brands Laboratories B.V., NL
GEH
Feb 24, 2026K260377XSense Cryoablation System with CryoProbes
IceCure Medical , Ltd., IL
GEH
Feb 13, 2026K251928CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with l
Medinice S.A., PL
GEH
Jan 12, 2026K251524Dr. Yglo Skin Tag Remover
Theotclab Healthcare B.V., NL
GEH
Dec 9, 2025K250742Focused Cryotherapy System
Focused Cryo, Inc.
GEH
Oct 16, 2025K253114TargetCool™ (RM-DT02W)
Recensmedical, Inc., KR
GEH
Oct 16, 2025K253000CryoFreeze Wart and Skin Tag Remover
Cryosurgery, Inc.
GEH
Oct 15, 2025K253348TargetCool-e
Recensmedical, Inc., KR
GEH
Oct 10, 2025K252903Verruca-Freeze H Plus
Cryosurgery, Inc.
GEH
May 22, 2025K251493Skin Clinic Freeze Point for Warts and Skin Tags
Cryoconcepts LP
GEH
Apr 15, 2025K242932Skin Clinic Nitro Clear Wart Remover
Cryoconcepts LP
GEH
Mar 13, 2025K243487CryoFreeze Wart and Skin Tag Remover
Cryosurgery, Inc.
GEH
Jan 29, 2025K243042Co-Ablation System with Sterile Co-Ablation Probe
Hygea Medical Technology Co., Ltd., CN
GEH
Jan 21, 2025K242288Advanced Cryo Wart Remover
Medical Brands Laboratories B.V., NL
GEH
Dec 3, 2024K243454Verruca-Freeze H
Cryosurgery, Inc.
GEH
Nov 6, 2024K242803Compound W Skin Tag Remover
Medtech Products, Inc.
GEH
Oct 25, 2024K242625Freeze Point & Private Label Versions
Cryoconcepts LP
GEH
Oct 18, 2024K243245IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straigh
Boston Scientific Corp
GEH
Sep 24, 2024K240776Celsio Flexible Cryocatheter System
Endocision Technologies, Inc., CA
GEH
Jul 24, 2024K240457C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)
Pentax of America, Inc.
GEH
Jun 28, 2024K240892XSense Cryoablation System with Cryoprobes
IceCure Medical , Ltd., IL
GEH
Jun 10, 2024K240106Histofreezer V
Cryoconcepts LP
GEH
Mar 13, 2024K234002ICEfx Cryoablation System (FPRCH8000-02)
Boston Scientific
GEH
Dec 4, 2023K233347Verruca-Freeze® H
Cryosurgery, Inc.
GEH
Nov 27, 2023K231661CryoThin™ Surgical System and Accessories
Medinux (Tianjin) Technologies Co., Ltd., CN
GEH
Nov 22, 2023K232635IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)
Boston Scientific
GEH
Aug 8, 2023K230551Visual-ICE Cryoablation System
Boston Scientific Corporation
GEH
Jun 22, 2023K230599TargetCool™
Recensmedical, Inc., KR
GEH
May 30, 2023K221897Hydrozid Precise
Bibawo Medical A/S, DK
GEH
May 18, 2023K222356Claritag Advanced
Dgi Technologies
GEH
Mar 28, 2023K230271ISOLIS Cryoprobe
Varian Medical Systems, Inc.
GEH
Dec 2, 2022K223369truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pac
STERIS Corporation
GEH
Aug 18, 2022K222272truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pac
STERIS Corporation
GEH
Jul 22, 2022K221234TargetCool
Recensmedical, Inc., KR
GEH
Jun 17, 2022K211099Freeze’n Clear Skin Clinic Warts & Tags
Cryoconcepts LP
GEH
Mar 31, 2022K220674TargetCool
Recensmedical, Inc., KR
GEH
Jan 5, 2022K211149Urethral Warming Catheter Kit
Varian Medical Systems, Inc.
GEH
Nov 29, 2021K212814C2 CryoBalloon Ablation System
Pentax of America, Inc.
GEH
Oct 22, 2021K210310CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit
Nuance Medical, LLC
GEH
Jul 7, 2021K201740Hydrozid
Medilink A/S, DK
GEH
May 13, 2021K203481CryoVIVE
Recensmedical, Inc., KR
GEH
May 6, 2021K210529Dr. Yglo Wart Remover
Theotclab Healthcare B.V., NL
GEH
Jan 21, 2021K201366Forwarts
Pronova Laboratories BV, NL
GEH
Dec 7, 2020K201183Vortex Radial Spray Catheter
CSA Medical, Inc.
GEH
Nov 24, 2020K203024C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal
Pentax of America, Inc.
GEH
Nov 2, 2020K203032IcePearl 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
Galil Medical, Inc.
GEH

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