GEH
- Product code
- GEH
- Device name
- Unit, Cryosurgical, Accessories
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.4350
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 29
- Summaries archived here
- 24 (direct download)
- 510(k) clearances (all years, FDA)
- 263 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (29)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261068 | 2026-06-30 | Serpex Medical | Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Car… | FDA |
| K261806 | 2026-06-09 | Erbe Elektromedizin GmbH | ERBECRYO 2 Cryosurgical Unit and Accessories | |
| K253230 | 2026-04-22 | Erbe Elektromedizin GmbH | ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECR… | |
| K252198 | 2026-04-02 | Medical Brands Laboratories B.V. | Advanced Cryo Skin Tag Remover (Advanced Skin Tag Re… | |
| K260377 | 2026-02-24 | IceCure Medical , Ltd. | XSense Cryoablation System with CryoProbes | |
| K251928 | 2026-02-13 | Medinice S.A. | CoolCryo - Cryoapplicator for cardiac cryoablation (… | |
| K251524 | 2026-01-12 | Theotclab Healthcare B.V. | Dr. Yglo Skin Tag Remover | FDA |
| K250742 | 2025-12-09 | Focused Cryo, Inc. | Focused Cryotherapy System | |
| K253000 | 2025-10-16 | Cryosurgery, Inc. | CryoFreeze Wart and Skin Tag Remover | |
| K253114 | 2025-10-16 | Recensmedical, Inc. | TargetCool (RM-DT02W) | FDA |
| K253348 | 2025-10-15 | Recensmedical, Inc. | TargetCool-e | |
| K252903 | 2025-10-10 | Cryosurgery, Inc. | Verruca-Freeze H Plus | |
| K251493 | 2025-05-22 | Cryoconcepts LP | Skin Clinic Freeze Point for Warts and Skin Tags | — |
| K242932 | 2025-04-15 | Cryoconcepts LP | Skin Clinic Nitro Clear Wart Remover | |
| K243487 | 2025-03-13 | Cryosurgery, Inc. | CryoFreeze Wart and Skin Tag Remover | |
| K243042 | 2025-01-29 | Hygea Medical Technology Co., Ltd. | Co-Ablation System with Sterile Co-Ablation Probe | |
| K242288 | 2025-01-21 | Medical Brands Laboratories B.V. | Advanced Cryo Wart Remover | |
| K243454 | 2024-12-03 | Cryosurgery, Inc. | Verruca-Freeze H | FDA |
| K242803 | 2024-11-06 | Medtech Products, Inc. | Compound W Skin Tag Remover | |
| K242625 | 2024-10-25 | Cryoconcepts LP | Freeze Point & Private Label Versions | |
| K243245 | 2024-10-18 | Boston Scientific Corp | IceSeed 1.5 CX Straight Needle (H7493968333170); Ice… | |
| K240776 | 2024-09-24 | Endocision Technologies, Inc. | Celsio Flexible Cryocatheter System | |
| K240457 | 2024-07-24 | Pentax of America, Inc. | C2 CryoBalloon Ablation System (C2 CryoBalloon Ablat… | |
| K240892 | 2024-06-28 | IceCure Medical , Ltd. | XSense Cryoablation System with Cryoprobes | |
| K240106 | 2024-06-10 | Cryoconcepts LP | Histofreezer V | |
| K234002 | 2024-03-13 | Boston Scientific | ICEfx Cryoablation System (FPRCH8000-02) | |
| K233347 | 2023-12-04 | Cryosurgery, Inc. | Verruca-Freeze® H | |
| K231661 | 2023-11-27 | Medinux (Tianjin) Technologies Co., Lt… | CryoThin Surgical System and Accessories | |
| K232635 | 2023-11-22 | Boston Scientific | IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed … |
Official FDA classification page: GEH
Classification and pathway per current FDA publications. Data from openFDA (CC0).