Cryoprobe
90-degree handle
3manufacturers in China registered for this device type
2catalogue numbers in this listing
4510(k) clearances naming this product code
1recall
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 | 2025-05-06 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Handling environment temperature -22 to 60 °C; Handling environment humidity 25 to 75 % RH; Handling environment atmospheric pressure 500 to 1000 millibar; Storage environment temperature 15 to 25 °C; Storage environment humidity 0 to 60 % RH |
| Packaging | Box of 5 |
| Sizes | Needle gauge 10 G; stent length 140 mm; shaft length 140 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CP-2004058 | Needle Gauge 10 G | In distribution |
| CP-2004059 | Needle Gauge 10 G | 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.