Product code GEH
- Device name
- Unit, Cryosurgical, Accessories
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4350
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261068 | Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000) | Serpex Medical | 2026-06-30 |
| K261806 | ERBECRYO 2 Cryosurgical Unit and Accessories | Erbe Elektromedizin GmbH | 2026-06-09 |
| K253230 | ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe | Erbe Elektromedizin GmbH | 2026-04-22 |
| K252198 | Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) | Medical Brands Laboratories B.V. | 2026-04-02 |
| K260377 | XSense Cryoablation System with CryoProbes | IceCure Medical , Ltd. | 2026-02-24 |
| 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 |
| K251524 | Dr. Yglo Skin Tag Remover | Theotclab Healthcare B.V. | 2026-01-12 |
| K250742 | Focused Cryotherapy System | Focused Cryo, Inc. | 2025-12-09 |
| K253000 | CryoFreeze Wart and Skin Tag Remover | Cryosurgery, Inc. | 2025-10-16 |
| K253114 | TargetCool™ (RM-DT02W) | Recensmedical, Inc. | 2025-10-16 |
| K253348 | TargetCool-e | Recensmedical, Inc. | 2025-10-15 |
| K252903 | Verruca-Freeze H Plus | Cryosurgery, Inc. | 2025-10-10 |
| K251493 | Skin Clinic Freeze Point for Warts and Skin Tags | Cryoconcepts LP | 2025-05-22 |
| K242932 | Skin Clinic Nitro Clear Wart Remover | Cryoconcepts LP | 2025-04-15 |
| K243487 | CryoFreeze Wart and Skin Tag Remover | Cryosurgery, Inc. | 2025-03-13 |
| K243042 | Co-Ablation System with Sterile Co-Ablation Probe | Hygea Medical Technology Co., Ltd. | 2025-01-29 |
| K242288 | Advanced Cryo Wart Remover | Medical Brands Laboratories B.V. | 2025-01-21 |
| K243454 | Verruca-Freeze H | Cryosurgery, Inc. | 2024-12-03 |
| K242803 | Compound W Skin Tag Remover | Medtech Products, Inc. | 2024-11-06 |
| K242625 | Freeze Point & Private Label Versions | Cryoconcepts LP | 2024-10-25 |
| 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 |
| K240776 | Celsio Flexible Cryocatheter System | Endocision Technologies, Inc. | 2024-09-24 |
| K240457 | C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) | Pentax of America, Inc. | 2024-07-24 |
| K240892 | XSense Cryoablation System with Cryoprobes | IceCure Medical , Ltd. | 2024-06-28 |
| K240106 | Histofreezer V | Cryoconcepts LP | 2024-06-10 |
| K234002 | ICEfx Cryoablation System (FPRCH8000-02) | Boston Scientific | 2024-03-13 |
| K233347 | Verruca-Freeze® H | Cryosurgery, Inc. | 2023-12-04 |
| K231661 | CryoThin™ Surgical System and Accessories | Medinux (Tianjin) Technologies Co., Ltd. | 2023-11-27 |
| K232635 | IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100) | Boston Scientific | 2023-11-22 |
| K230551 | Visual-ICE Cryoablation System | Boston Scientific Corporation | 2023-08-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00884450457573 | C2 CryoBalloon™ | Merit Medical Systems, Inc. | 2026-06-02 |
| 00884450457566 | C2 CryoBalloon™ | Merit Medical Systems, Inc. | 2026-06-02 |
| 00884450457528 | C2 CryoBalloon™ | Merit Medical Systems, Inc. | 2026-06-02 |
| 00884450457511 | C2 CryoBalloon™ | Merit Medical Systems, Inc. | 2026-06-02 |
| 10840143902673 | cryoICE® System | ATRICURE, INC. | 2026-05-27 |
| 10840143902666 | cryoICE® System | ATRICURE, INC. | 2026-05-27 |
| 08800073100148 | TargetCool-e | RecensMedical, Inc. | 2026-05-14 |
| 00810563022063 | 2.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, Spherical | Varian Medical Systems, Inc. | 2023-04-20 |
| 00810563022056 | 2.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, Ellipsoidal | Varian Medical Systems, Inc. | 2023-04-20 |
| 00810563022049 | 2.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, Spherical | Varian Medical Systems, Inc. | 2023-04-20 |
| 00810563022032 | 2.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, Ellipsoidal | Varian Medical Systems, Inc. | 2023-04-20 |
| 08800073100049 | TargetCool | RecensMedical, Inc. | 2022-11-29 |
| 00816389028913 | 2.4mm V-Probe™ Cryoprobe | Varian Medical Systems, Inc. | 2022-02-18 |
| 00816389028920 | 2.4mm V-Probe™ Cryoprobe Right Angle | Varian Medical Systems, Inc. | 2022-02-18 |
| 00810563020687 | 2.4mm V-Probe™ Cryoprobe Right Angle | Varian Medical Systems, Inc. | 2022-02-18 |
| 00816389028906 | 2.4mm V-Probe™ Cryoprobe | Varian Medical Systems, Inc. | 2022-02-18 |
| 00810563020939 | Prostate Procedure Probe Pack | Varian Medical Systems, Inc. | 2022-02-18 |
| 00810563020915 | Prostate Procedure Probe Pack | Varian Medical Systems, Inc. | 2022-02-18 |
| 00810563020908 | TempProbe™ Device | Varian Medical Systems, Inc. | 2022-02-18 |
| 00810563020892 | 3.8 mm Long Shaft RenalCryo™ Cryoprobe | Varian Medical Systems, Inc. | 2022-02-18 |
| 00810563020885 | 3.8 mm Long Shaft RenalCryo™ Cryoprobe | Varian Medical Systems, Inc. | 2022-02-18 |
| 00810563020878 | 3.8 mm RenalCryo™ Cryoprobe | Varian Medical Systems, Inc. | 2022-02-18 |
| 00810563020861 | 3.8 mm RenalCryo™ Cryoprobe | Varian Medical Systems, Inc. | 2022-02-18 |
| 00810563020847 | 2.4mm Long Shaft RenalCryo™ Cryoprobe | Varian Medical Systems, Inc. | 2022-02-18 |
| 00810563020823 | 2.4mm RenalCryo™ Cryoprobe | Varian Medical Systems, Inc. | 2022-02-18 |
| 00810563020816 | 1.7 mm Long Shaft RenalCryo™ Cryoprobe | Varian Medical Systems, Inc. | 2022-02-18 |
| 00810563020809 | 1.7 mm Long Shaft RenalCryo™ Cryoprobe | Varian Medical Systems, Inc. | 2022-02-18 |
| 00810563020793 | 1.7 mm RenalCryo™ Cryoprobe | Varian Medical Systems, Inc. | 2022-02-18 |
| 00810563020786 | 1.7 mm RenalCryo™ Cryoprobe | Varian Medical Systems, Inc. | 2022-02-18 |
| 08800073100018 | TargetCool | RecensMedical, Inc. | 2021-06-25 |