GEH — Unit, Cryosurgical, Accessories Class II
FDA Device Classification
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 |
|---|
| K260377 | icecure medical | XSense Cryoablation System with CryoProbes | February 24, 2026 |
| K251928 | medinice | CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control | February 13, 2026 |
| K251524 | theotclab healthcare | Dr. Yglo Skin Tag Remover | January 12, 2026 |
| K250742 | focused cryo | Focused Cryotherapy System | December 9, 2025 |
| K253000 | cryosurgery | CryoFreeze Wart and Skin Tag Remover | October 16, 2025 |
| K253114 | recensmedical | TargetCool (RM-DT02W) | October 16, 2025 |
| K253348 | recensmedical | TargetCool-e | October 15, 2025 |
| K252903 | cryosurgery | Verruca-Freeze H Plus | October 10, 2025 |
| K251493 | cryoconcepts | Skin Clinic Freeze Point for Warts and Skin Tags | May 22, 2025 |
| K242932 | cryoconcepts | Skin Clinic Nitro Clear Wart Remover | April 15, 2025 |
| K243487 | cryosurgery | CryoFreeze Wart and Skin Tag Remover | March 13, 2025 |
| K243042 | hygea medical technology co | Co-Ablation System with Sterile Co-Ablation Probe | January 29, 2025 |
| K242288 | medical brands laboratories | Advanced Cryo Wart Remover | January 21, 2025 |
| K243454 | cryosurgery | Verruca-Freeze H | December 3, 2024 |
| K242803 | medtech products | Compound W Skin Tag Remover | November 6, 2024 |
| K242625 | cryoconcepts | Freeze Point & Private Label Versions | October 25, 2024 |
| K243245 | boston scientific | IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle | October 18, 2024 |
| K240776 | endocision technologies | Celsio Flexible Cryocatheter System | September 24, 2024 |
| K240457 | pentax of america | C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) | July 24, 2024 |
| K240892 | icecure medical | XSense Cryoablation System with Cryoprobes | June 28, 2024 |