AtriCure cryoICE cryoFORM Cryoablation System (Cryof)
The AtriCure cryoICE cryoFORM probe freezes targeted tissue during cardiac surgery to treat arrhythmias by interrupting electrical conduction. It is a sterile, single-use cryosurgical…
The AtriCure cryoICE cryoFORM probe freezes targeted tissue during cardiac surgery to treat arrhythmias by interrupting electrical conduction. It is a sterile, single-use cryosurgical handpiece connected to the AtriCure Cryo Module.
High-pressure nitrous oxide expands within the probe to cool its tip. The malleable cryotip can be shaped for the anatomy, and the connected thermocouple provides temperature information to the console during freezing.
Listed Item
cryoICE cryoFORM Corrugated 10cm Cryoablation Probe
Probe Shape
The 4 mm diameter cryotip is malleable along its 10 cm length. A forming tool bends it to the required shape, while the insulated shaft permits adjustment of the exposed therapeutic length up to 10 cm.
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 | Atricure, Inc., United States |
|---|---|
| FDA product code | GEH |
| Device type | Unit, Cryosurgical, Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4350 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K180137 |
| Record published | 2020-03-18 |
| Record revised | 2021-04-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Box, case of 3 |
| Sizes | Length 10 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CRYOF | Length 10 cm | In distribution |
| CRYOF | Length 10 cm | 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 |
|---|---|
| K180137 | 2018-02-15 |
| K152337 | 2016-03-22 |
| K142441 | 2014-10-29 |
| K140058 | 2014-01-24 |
| K121507 | 2012-06-06 |
| K112072 | 2011-08-03 |
| K111042 | 2011-05-26 |
| K082074 | 2009-03-02 |
Recalls
3 of these are 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 |
|---|---|---|---|---|---|
| 2023-11-28 | Class II | Other | AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. These tank hose assemblies were provided with an outer sheathing that does not have required pin perforations | 1 | |
| 2023-11-28 | Class II | Other | AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. These tank hose assemblies were provided with an outer sheathing that does not have required pin perforations | 35 | |
| 2014-11-21 | Class II | Packaging process control | Affected product may have compromised sterility due to packaging defects. It was determined that some mishandling of the product during the packaging process could inadvertently damage the sterile barrier. | 19,190 units | 2015-07-20 |
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.