GEH · Unit, Cryosurgical, Accessories
General, Plastic Surgery · 21 CFR 878.4350 · Class 2
Overview
| Product Code | GEH |
|---|---|
| Device Name | Unit, Cryosurgical, Accessories |
| Regulation | 21 CFR 878.4350 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| 3rd-Party Reviewable | Yes |
Identification
(1) Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. (2) Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold. (3) Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 260)
Showing 20 most recent of 260 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252198 | Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) | Medical Brands Laboratories B.V. | Apr 2, 2026 | SESE |
| K260377 | XSense Cryoablation System with CryoProbes | IceCure Medical , Ltd. | Feb 24, 2026 | SESE |
| K251928 | CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21) | Medinice S.A. | Feb 13, 2026 | SESE |
| K251524 | Dr. Yglo Skin Tag Remover | Theotclab Healthcare B.V. | Jan 12, 2026 | SESE |
| K250742 | Focused Cryotherapy System | Focused Cryo, Inc. | Dec 9, 2025 | SESE |
| K253114 | TargetCool (RM-DT02W) | Recensmedical, Inc. | Oct 16, 2025 | SESE |
| K253000 | CryoFreeze Wart and Skin Tag Remover | Cryosurgery, Inc. | Oct 16, 2025 | SESE |
| K253348 | TargetCool-e | Recensmedical, Inc. | Oct 15, 2025 | SESE |
| K252903 | Verruca-Freeze H Plus | Cryosurgery, Inc. | Oct 10, 2025 | SESE |
| K251493 | Skin Clinic Freeze Point for Warts and Skin Tags | Cryoconcepts LP | May 22, 2025 | SESE |
| K242932 | Skin Clinic Nitro Clear Wart Remover | Cryoconcepts LP | Apr 15, 2025 | SESE |
| K243487 | CryoFreeze Wart and Skin Tag Remover | Cryosurgery, Inc. | Mar 13, 2025 | SESE |
| K243042 | Co-Ablation System with Sterile Co-Ablation Probe | Hygea Medical Technology Co., Ltd. | Jan 29, 2025 | SESE |
| K242288 | Advanced Cryo Wart Remover | Medical Brands Laboratories B.V. | Jan 21, 2025 | SESE |
| K243454 | Verruca-Freeze H | Cryosurgery, Inc. | Dec 3, 2024 | SESE |
| K242803 | Compound W Skin Tag Remover | Medtech Products, Inc. | Nov 6, 2024 | SESE |
| K242625 | Freeze Point & Private Label Versions | Cryoconcepts LP | Oct 25, 2024 | SESE |
| K243245 | IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) | Boston Scientific Corp | Oct 18, 2024 | SESE |
| K240776 | Celsio Flexible Cryocatheter System | Endocision Technologies, Inc. | Sep 24, 2024 | SESE |
| K240457 | C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) | Pentax of America, Inc. | Jul 24, 2024 | SESE |
Top Applicants
- Galil Medical , Ltd. — 22 clearances
- CSA Medical, Inc. — 14 clearances
- Endocare, Inc. — 13 clearances
- Cryomedical Sciences, Inc. — 9 clearances
- AtriCure, Inc. — 8 clearances
