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 |
|---|---|---|---|
| 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 |
| K253114 | TargetCool™ (RM-DT02W) | Recensmedical, Inc. | 2025-10-16 |
| K253000 | CryoFreeze Wart and Skin Tag Remover | Cryosurgery, 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 |
| K230599 | TargetCool™ | Recensmedical, Inc. | 2023-06-22 |
| K221897 | Hydrozid Precise | Bibawo Medical A/S | 2023-05-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10840143902673 | cryoICE® System | ATRICURE, INC. | 2026-05-27 |
| 10840143902680 | cryoICE® System | ATRICURE, INC. | 2026-05-27 |
| 10840143902697 | cryoICE® System | ATRICURE, INC. | 2026-05-27 |
| 10840143902703 | cryoICE® System | ATRICURE, INC. | 2026-05-27 |
| 10840143902710 | cryoICE® System | ATRICURE, INC. | 2026-05-27 |
| 10840143902727 | cryoICE® System | ATRICURE, INC. | 2026-05-27 |
| 10840143902734 | cryoICE® System | ATRICURE, INC. | 2026-05-27 |
| 30840143904343 | cryoICE® System | ATRICURE, INC. | 2026-05-27 |
| 30840143912164 | AtriCure® cryoICE® BOX | ATRICURE, INC. | 2026-05-27 |
| 10840143902666 | cryoICE® System | ATRICURE, INC. | 2026-05-27 |
| 08800073100148 | TargetCool-e | RecensMedical, Inc. | 2026-05-14 |
| 08720618589002 | Dr Yglo | TheOTCLab B.V. | 2025-04-23 |
| 10840143902505 | AtriCure cryoICE cryoFORM Cryoablation System (CRYOF) | ATRICURE, INC. | 2021-01-08 |
| 10840143902468 | cryoICE Cryoablation System | ATRICURE, INC. | 2021-01-08 |
| 10840143902420 | AtriCure cryoICE Cryoablation System (CRYO3) | ATRICURE, INC. | 2021-01-08 |
| 10840143902383 | cryoICE Cryoablation System | ATRICURE, INC. | 2021-01-08 |
| 10612479220093 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2017-08-02 |
| 10381780171959 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-08 |
| 10381780171966 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-08 |
| 10381780171898 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-25 |
| 10381780171973 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-23 |
| 10381780171935 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-16 |
| 10381780171942 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-16 |
| 10381780171980 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-16 |
| 10381780171997 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-16 |
| 10381780172000 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-16 |
| 10381780177098 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-16 |
| 10381780171928 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-16 |
| 10381780171911 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-16 |
| 10381780171904 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-16 |