Hygea
The Sterile Co-Ablation Probe, used in conjunction with the Co-Ablation System, is designed to destroy solid tumors, intended for use in open, minimally invasive or endoscopic surgical…
The Sterile Co-Ablation Probe, used in conjunction with the Co-Ablation System, is designed to destroy solid tumors, intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to Co-Ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.
Who Else Makes It
Concentrated in Guangdong (1), Beijing (1), Tianjin (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Kesite Digital Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 4 |
| Hygea Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
| Medinux (Tianjin) Technologies Co., Ltd. | Tianjin | Tianjin | Manufacturer | 1 |
Record
| Listed by | Hygea Medical Technology Co., Ltd., China |
|---|---|
| FDA product code | GEH |
| Device type | Unit, Cryosurgical, Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4350 |
| Establishment | Manufacturer |
| 510(k) | K243042 |
| Record published | 2025-09-08 |
| Record revised | 2025-11-20 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Elite RCL17 | In distribution | |
| Elite RCX17 | In distribution | |
| Elite RBX20 | In distribution | |
| Elite ABS20 | In distribution | |
| Elite RBL26 | In distribution | |
| Elite RBS26 | In distribution | |
| Elite RCS17 | In distribution | |
| Elite ADL26 | In distribution | |
| Ease TMS15 | In distribution | |
| Elite RBL20 | In distribution | |
| AI Epic S20U | In distribution | |
| Ease TSL08 | In distribution | |
| Elite ACL17 | In distribution | |
| Elite RAS30 | In distribution | |
| Elite RBX26 | In distribution | |
| AI Epic S40U | In distribution | |
| Ease TML15 | In distribution | |
| Elite RAL30 | In distribution | |
| Elite ACX17 | In distribution | |
| Elite ACS17 | In distribution | |
| Elite ABL20 | In distribution | |
| Ease TSS08 | In distribution | |
| Elite RAL26 | In distribution | |
| Elite RAS26 | In distribution | |
| Elite RBS20 | In distribution | |
| Elite ABX20 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Frigitronics | Coopersurgical, Inc. | 42 |
| CryoProbe™ | H&O Equipments, Nv/Sa | 35 |
| Wallach | Coopersurgical, Inc. | 32 |
| Premier | Premier Dental Products Co. | 30 |
| truFreeze | CSA Medical | 20 |
| Freezpen® | H&O Equipments, Nv/Sa | 19 |
| Leisegang Cryotip for LM-900 | Coopersurgical, Inc. | 15 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 13 |
| cryoICE Cryoablation System | Atricure, Inc. | 13 |
| CryoThin | Medinux (Tianjin) Technologies Co., Ltd. | 12 |
| Erbe | Erbe Elektromedizin GmbH | 12 |
| CVS Health | Woonsocket Prescription Center, Incorporated | 10 |
Showing 12 of 334. All products under Unit, Cryosurgical, Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243042 | 2025-01-29 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.