XSense Cryoablation System
XSense Cryoablation System destroys tissue by freezing it during surgical procedures. CryoProbes receive pressurized liquid nitrogen from an internal dewar, and its change from liquid to…
XSense Cryoablation System destroys tissue by freezing it during surgical procedures. CryoProbes receive pressurized liquid nitrogen from an internal dewar, and its change from liquid to gas at the probe tip transfers heat away from the contacted tissue.
The system is used in a professional healthcare environment with an imaging system, such as ultrasound, for real-time visualization during the procedure. The probe tip provides the treatment interface at the tissue.
System Accessories
The range includes two CryoProbe configurations, an introducer and a holder. An external 25 litre dewar with a supporting cart is also included among the system’s accessories.
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 | Icecure Medical Ltd., Israel |
|---|---|
| FDA product code | GEH |
| Device type | Unit, Cryosurgical, Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4350 |
| Establishment | Manufacturer |
| 510(k) | K240892 |
| Record published | 2025-05-05 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature -20 to 70 °C; Handling environment humidity 30 to 75 % RH; Handling environment atmospheric pressure 500 to 1000 millibar; Storage environment temperature 10 to 40 °C; Storage environment humidity 30 to 60 % RH |
| Sizes | Weight 83 kg; height 162 cm; depth 56 cm; width 46 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CSS-2004054 | Weight 83 kg | 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 |
|---|---|
| K260377 | 2026-02-24 |
| K240892 | 2024-06-28 |
| K183213 | 2019-12-20 |
| K102360 | 2010-11-29 |
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 |
|---|---|---|---|---|
| 2019-09-16 | Class II | Other | Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe) | 16 units |
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.