Varian Cryocare Touch™ System
The Varian Cryocare Touch System freezes and ablates tissue using extreme cold delivered through Endocare cryoprobes. It supports open, minimally invasive and endoscopic surgical…
The Varian Cryocare Touch System freezes and ablates tissue using extreme cold delivered through Endocare cryoprobes. It supports open, minimally invasive and endoscopic surgical procedures, with indications spanning specified tumors, skin lesions and other tissue treatments.
The system uses the Joule-Thomson effect with argon and helium gases. High-pressure argon circulated through a cryoprobe produces cooling, while helium provides active thawing. Cooling and warming occur at the distal end of the probe shaft, under software control from the console.
Monitoring and Connections
The console has a 15-inch touchscreen, eight cryoprobe connections and eight TempProbe connections. Separate temperature probes monitor tissue in or around the targeted freeze zone. Wheels with locks and side handles support movement of the console.
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 | Varian Medical Systems, Inc, United States |
|---|---|
| FDA product code | GEH |
| Device type | Unit, Cryosurgical, Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4350 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K201588 |
| Record published | 2020-08-14 |
| Record revised | 2025-10-13 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CRYO-38T | 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 |
| Hygea | Hygea Medical Technology Co., Ltd. | 26 |
| 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 |
Showing 12 of 334. All products under Unit, Cryosurgical, Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230271 | 2023-03-28 |
| K211149 | 2022-01-05 |
| K201588 | 2020-08-11 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2012-12-20 | Class II | Incorrect or no expiration date | The Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has the incorrect expiration date. | 50 units | 2013-04-22 |
| 2012-02-27 | Not classified | Labeling mix-ups | HealthTronics has initiated this recall of these products because there have been instances where the temperature probes (aka TempProbes) in the kit may be mislabeled. In some instances, the label near the prove does not match the label at | 9274 units | 2013-03-19 |
| 2010-11-04 | Not classified | Other | Mislabeled : The label on the outer box and inner pouch of the EndoCare 2.4mm CryoProbe (CRYO-44F) inaccurately reference the CVA2400 (2.4mm Variable Probe aka: V-Probe). | 33 Units | 2011-04-14 |
| 2008-12-05 | Not classified | Other | Endocare received a report of a patient death that occurred during a prostate cryoablation procedure. An autopsy attributed the cause of death to an air embolism. The safety notice for the cryoprobes was issued to refocus attention on t | 22,741 units total for all products | 2010-10-21 |
| 2008-12-05 | Not classified | Other | Endocare received a report of a patient death that occurred during a prostate cryoablation procedure. An autopsy attributed the cause of death to an air embolism. The safety notice for the cryoprobes was issued to refocus attention on th | 22,741 units total for all products | 2010-10-21 |
| 2002-10-25 | Not classified | Other | Device design failure, connectivity. | 933 | 2003-04-15 |
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.