GEH — Unit, Cryosurgical, Accessories Class II
FDA product code GEH covers "Unit, Cryosurgical, Accessories", a Class II medical device regulated under 21 CFR 878.4350. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GEH
- Device Class
- Class II
- Regulation Number
- 878.4350
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K262420 | Serpex Medical | Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000) | Sep 2, 2026 |
| K261068 | Serpex Medical | Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000) | Jun 30, 2026 |
| K261806 | Erbe Elektromedizin | ERBECRYO 2 Cryosurgical Unit and Accessories | Jun 9, 2026 |
| K253230 | Erbe Elektromedizin | ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe | Apr 22, 2026 |
| K252198 | Medical Brands Laboratories | Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) | Apr 2, 2026 |
| K260377 | Icecure Medical | XSense Cryoablation System with CryoProbes | Feb 24, 2026 |
| K251928 | Medinice | CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control | Feb 13, 2026 |
| K251524 | Theotclab Healthcare | Dr. Yglo Skin Tag Remover | Jan 12, 2026 |
| K250742 | Focused Cryo | Focused Cryotherapy System | Dec 9, 2025 |
| K253000 | Cryosurgery | CryoFreeze Wart and Skin Tag Remover | Oct 16, 2025 |
| K253114 | Recensmedical | TargetCool (RM-DT02W) | Oct 16, 2025 |
| K253348 | Recensmedical | TargetCool-e | Oct 15, 2025 |
| K252903 | Cryosurgery | Verruca-Freeze H Plus | Oct 10, 2025 |
| K251493 | Cryoconcepts | Skin Clinic Freeze Point for Warts and Skin Tags | May 22, 2025 |
| K242932 | Cryoconcepts | Skin Clinic Nitro Clear Wart Remover | Apr 15, 2025 |
| K243487 | Cryosurgery | CryoFreeze Wart and Skin Tag Remover | Mar 13, 2025 |
| K243042 | Hygea Medical Technology Co | Co-Ablation System with Sterile Co-Ablation Probe | Jan 29, 2025 |
| K242288 | Medical Brands Laboratories | Advanced Cryo Wart Remover | Jan 21, 2025 |
| K243454 | Cryosurgery | Verruca-Freeze H | Dec 3, 2024 |
| K242803 | Medtech Products | Compound W Skin Tag Remover | Nov 6, 2024 |