FDA Product Code
FDA Product Code GEH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4350
510(k) Clearances — 264 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262420 | Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000) | Serpex Medical | 2026-09-02 | Traditional | PDF ↗ |
| K261068 | Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000) | Serpex Medical | 2026-06-30 | Traditional | PDF ↗ |
| K261806 | ERBECRYO 2 Cryosurgical Unit and Accessories | Erbe Elektromedizin GmbH | 2026-06-09 | Special | PDF ↗ |
| K253230 | ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe | Erbe Elektromedizin GmbH | 2026-04-22 | Traditional | PDF ↗ |
| K252198 | Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) | Medical Brands Laboratories B.V. | 2026-04-02 | Traditional | PDF ↗ |
| K260377 | XSense Cryoablation System with CryoProbes | IceCure Medical , Ltd. | 2026-02-24 | Special | PDF ↗ |
| K251928 | CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21) | Medinice S.A. | 2026-02-13 | Traditional | PDF ↗ |
| K251524 | Dr. Yglo Skin Tag Remover | Theotclab Healthcare B.V. | 2026-01-12 | Traditional | PDF ↗ |
| K250742 | Focused Cryotherapy System | Focused Cryo, Inc. | 2025-12-09 | Traditional | PDF ↗ |
| K253000 | CryoFreeze Wart and Skin Tag Remover | Cryosurgery, Inc. | 2025-10-16 | Special | PDF ↗ |
| K253114 | TargetCool (RM-DT02W) | Recensmedical, Inc. | 2025-10-16 | Special | PDF ↗ |
| K253348 | TargetCool-e | Recensmedical, Inc. | 2025-10-15 | Traditional | PDF ↗ |
| K252903 | Verruca-Freeze H Plus | Cryosurgery, Inc. | 2025-10-10 | Special | PDF ↗ |
| K251493 | Skin Clinic Freeze Point for Warts and Skin Tags | Cryoconcepts LP | 2025-05-22 | Special | PDF ↗ |
| K242932 | Skin Clinic Nitro Clear Wart Remover | Cryoconcepts LP | 2025-04-15 | Traditional | PDF ↗ |
| K243487 | CryoFreeze Wart and Skin Tag Remover | Cryosurgery, Inc. | 2025-03-13 | Traditional | PDF ↗ |
| K243042 | Co-Ablation System with Sterile Co-Ablation Probe | Hygea Medical Technology Co., Ltd. | 2025-01-29 | Traditional | PDF ↗ |
| K242288 | Advanced Cryo Wart Remover | Medical Brands Laboratories B.V. | 2025-01-21 | Traditional | PDF ↗ |
| K243454 | Verruca-Freeze H | Cryosurgery, Inc. | 2024-12-03 | Special | PDF ↗ |
| K242803 | Compound W Skin Tag Remover | Medtech Products, Inc. | 2024-11-06 | Traditional | PDF ↗ |
| K242625 | Freeze Point & Private Label Versions | Cryoconcepts LP | 2024-10-25 | Traditional | PDF ↗ |
| K243245 | IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) | Boston Scientific Corp | 2024-10-18 | Special | PDF ↗ |
| K240776 | Celsio Flexible Cryocatheter System | Endocision Technologies, Inc. | 2024-09-24 | Traditional | PDF ↗ |
| K240457 | C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) | Pentax of America, Inc. | 2024-07-24 | Traditional | PDF ↗ |
| K240892 | XSense Cryoablation System with Cryoprobes | IceCure Medical , Ltd. | 2024-06-28 | Traditional | PDF ↗ |
| K240106 | Histofreezer V | Cryoconcepts LP | 2024-06-10 | Traditional | PDF ↗ |
| K234002 | ICEfx Cryoablation System (FPRCH8000-02) | Boston Scientific | 2024-03-13 | Traditional | PDF ↗ |
| K233347 | Verruca-Freeze® H | Cryosurgery, Inc. | 2023-12-04 | Traditional | PDF ↗ |
| K231661 | CryoThin Surgical System and Accessories | Medinux (Tianjin) Technologies Co., Ltd. | 2023-11-27 | Traditional | PDF ↗ |
| K232635 | IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100) | Boston Scientific | 2023-11-22 | Special | PDF ↗ |
| K230551 | Visual-ICE Cryoablation System | Boston Scientific Corporation | 2023-08-08 | Traditional | PDF ↗ |
| K230599 | TargetCool | Recensmedical, Inc. | 2023-06-22 | Traditional | PDF ↗ |
| K221897 | Hydrozid Precise | Bibawo Medical A/S | 2023-05-30 | Traditional | PDF ↗ |
| K222356 | Claritag Advanced | Dgi Technologies | 2023-05-18 | Traditional | PDF ↗ |
| K230271 | ISOLIS Cryoprobe | Varian Medical Systems, Inc. | 2023-03-28 | Traditional | PDF ↗ |
| 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 | STERIS Corporation | 2022-12-02 | Special | PDF ↗ |
| 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 | STERIS Corporation | 2022-08-18 | Special | PDF ↗ |
| K221234 | TargetCool | Recensmedical, Inc. | 2022-07-22 | Traditional | PDF ↗ |
| K211099 | Freezen Clear Skin Clinic Warts & Tags | Cryoconcepts LP | 2022-06-17 | Traditional | PDF ↗ |
| K220674 | TargetCool | Recensmedical, Inc. | 2022-03-31 | Special | PDF ↗ |
| K211149 | Urethral Warming Catheter Kit | Varian Medical Systems, Inc. | 2022-01-05 | Traditional | PDF ↗ |
| K212814 | C2 CryoBalloon Ablation System | Pentax of America, Inc. | 2021-11-29 | Traditional | PDF ↗ |
| K210310 | CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit | Nuance Medical, LLC | 2021-10-22 | Traditional | PDF ↗ |
| K201740 | Hydrozid | Medilink A/S | 2021-07-07 | Traditional | PDF ↗ |
| K203481 | CryoVIVE | Recensmedical, Inc. | 2021-05-13 | Traditional | PDF ↗ |
| K210529 | Dr. Yglo Wart Remover | Theotclab Healthcare B.V. | 2021-05-06 | Traditional | PDF ↗ |
| K201366 | Forwarts | Pronova Laboratories BV | 2021-01-21 | Traditional | PDF ↗ |
| K201183 | Vortex Radial Spray Catheter | CSA Medical, Inc. | 2020-12-07 | Traditional | PDF ↗ |
| K203024 | C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge | Pentax of America, Inc. | 2020-11-24 | Traditional | PDF ↗ |
| 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 | Galil Medical, Inc. | 2020-11-02 | Special | PDF ↗ |
| K201260 | Dermal Cooling System | R2 Technologies, Inc. | 2020-09-24 | Traditional | PDF ↗ |
| K201588 | CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice | Varian Medical Systems, Inc. | 2020-08-11 | Traditional | PDF ↗ |
| K193665 | Frozen N | Yozma Bmtech Co., Ltd. | 2020-05-28 | Traditional | PDF ↗ |
| K193619 | Cry-Ac®, Cry-Ac-3®, Cry-Baby | Brymill Cryogenic Systems | 2020-03-25 | Traditional | PDF ↗ |
| 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 | Erbe Elektromedizin GmbH | 2020-01-07 | Traditional | PDF ↗ |
| K183213 | IceSense 3, ProSense, MultiSense | IceCure Medical , Ltd. | 2019-12-20 | Traditional | PDF ↗ |
| K190747 | Claritag | Dgi Technologies | 2019-10-31 | Traditional | PDF ↗ |
| K190194 | C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge | Pentax Medical, A Division of Pentax of America, Inc. | 2019-05-31 | Traditional | PDF ↗ |
| K190407 | CryoLab | Cryoconcepts LP | 2019-04-22 | Traditional | PDF ↗ |
| K183601 | CryoTouch | Cryoconcepts LP | 2019-04-18 | Traditional | PDF ↗ |
| K190356 | ClariFix | Arrinex, Inc. | 2019-02-26 | Special | PDF ↗ |
| K182392 | Frozen C | B.M. Tech. Worldwide Co., Ltd. | 2018-10-30 | Traditional | PDF ↗ |
| K181741 | IceSphere 1.5 CX Cryoablation Needle | Galil Medical , Ltd. | 2018-07-30 | Special | PDF ↗ |
| K181153 | ICEfx Cryoablation System | Galil Medical, Inc. | 2018-05-15 | Special | PDF ↗ |
| K180211 | Freezpoint | Bovie Medical Corp. | 2018-03-21 | Traditional | PDF ↗ |
| K180137 | AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF) | AtriCure, Inc. | 2018-02-15 | Special | PDF ↗ |
| K163684 | C2 CryoBalloon Ablation System | C2 Therapeutics, Inc. | 2018-01-23 | Traditional | PDF ↗ |
| K172769 | CryOmega Flexx | Cryoconcepts LP | 2017-11-30 | Traditional | PDF ↗ |
| K173037 | Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel | Galil Medical, Inc. | 2017-11-21 | Traditional | PDF ↗ |
| K172373 | Compound W Nitro-Freeze | Medtech Products, Inc. | 2017-11-02 | Traditional | PDF ↗ |
| K170810 | CRYOFOS | Cryofos Medical GmbH | 2017-09-27 | Traditional | PDF ↗ |
| K171626 | truFreeze System | CSA Medical, Inc. | 2017-08-30 | Traditional | PDF ↗ |
| K172049 | CryoIQ DERM, CryoIQ PRO, CryoIQ EquiMED | Cry IQ AB | 2017-08-30 | Traditional | PDF ↗ |
| K172041 | truFreeze System | CSA Medical, Inc. | 2017-07-27 | Special | PDF ↗ |
| K171522 | truFreeze Rapid AV Spray Kit | CSA Medical, Inc. | 2017-07-14 | Traditional | PDF ↗ |
| K171398 | Dermal Cooling System | R2 Dermatology ,Inc | 2017-07-06 | Traditional | PDF ↗ |
| K163244 | truFreeze System | CSA Medical, Inc. | 2017-05-24 | Traditional | PDF ↗ |
| K162608 | ClariFix Device | Arrinex, Inc. | 2017-02-14 | Traditional | PDF ↗ |
| K161202 | C2 Cryoballoon Ablation System | C2 Therapeutics, Inc. | 2017-01-05 | Traditional | PDF ↗ |
| K162695 | truFreeze System | CSA Medical, Inc. | 2016-10-25 | Special | PDF ↗ |
| K162599 | IcePearl 2.1 CX L, IceForce 2.1 CX L | Galil Medical , Ltd. | 2016-10-11 | Special | PDF ↗ |
| K161480 | R2 Dermal Cooling System | R2 Dermatology | 2016-10-05 | Traditional | PDF ↗ |
| K161294 | Compound W Wart Removal System Dual Power | Medtech Products, Inc. | 2016-09-15 | Traditional | PDF ↗ |
| K161615 | Accurett | H&O Equipments, Nv/Sa | 2016-08-23 | Special | PDF ↗ |
| K161557 | truFreeze System | CSA Medical, Inc. | 2016-07-26 | Traditional | PDF ↗ |
| K161337 | CryoDose H or Similar | Nuance Medical, LLC | 2016-07-12 | Traditional | PDF ↗ |
| K161296 | Cool Renewal | Cool Renewal, LLC | 2016-07-06 | Traditional | PDF ↗ |
| K160669 | ClariFix Device | Arrinex, Inc. | 2016-06-24 | Traditional | PDF ↗ |
| K160994 | C2 CryoBalloon Focal Pear Catheter | C2 Therapeutics, Inc. | 2016-05-19 | Special | PDF ↗ |
| K152329 | Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System | C2 Therapeutics, Inc. | 2016-04-13 | Traditional | PDF ↗ |
| K160273 | truFreeze System | Csa Medial, Inc. | 2016-03-25 | Traditional | PDF ↗ |
| K152337 | cryoFORM cryoICE cryoablation probe | AtriCure, Inc. | 2016-03-22 | Traditional | PDF ↗ |
| K153489 | Cryocare CS Surgical System | Healthtronics | 2016-02-05 | Traditional | PDF ↗ |
| K153541 | Coldplay CryoBalloon® Ablation System | C2 Therapeutics, Inc. | 2016-01-07 | Special | PDF ↗ |
| K152203 | UTERMOHLEN CRYO PROFESSIONAL | Koninklijke (Royal) Utermohlen | 2015-11-06 | Traditional | PDF ↗ |
| K152668 | truFreeze System | CSA Medical, Inc. | 2015-10-14 | Special | PDF ↗ |
| K151968 | Cryocare CS-3 Surgical System version 5 | Healthtronics | 2015-09-09 | Traditional | PDF ↗ |
| 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 | Galil Medical , Ltd. | 2015-08-28 | Special | PDF ↗ |
| K151309 | Wartie Advanced Wart Remover or other proprietary name | Youmedical Corp BV | 2015-08-14 | Traditional | PDF ↗ |
| K151054 | Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System | C2 Therapeutics, Inc. | 2015-07-07 | Special | PDF ↗ |
Product code GEH · Class II · General, Plastic Surgery. Data: openFDA.