cryoICE Cryoablation System
cryoICE cryoFORM 10 cm Corrugated Stainless Steel Cryoablation Probe
3manufacturers in China registered for this device type
13catalogue numbers in this listing
8510(k) clearances naming this product code
3recalls on this code
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) | K142441 |
| Record published | 2016-10-24 |
| Record revised | 2021-04-07 (version 4) |
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, manufacturing date, serial number |
| Storage | Storage environment temperature -35 to 54 °C; Storage environment humidity 15 to 90 % RH |
| Packaging | Box, case of 3 |
| Sizes | Length 10 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CRYO3 | Length 10 cm | In distribution |
| CRYO3 | Length 10 cm | In distribution |
| ACM1 | In distribution | |
| ACM1 | In distribution | |
| CRYOF | Length 10 cm | In distribution |
| ACM1 | In distribution | |
| ACM | In distribution | |
| CRYOF | Length 10 cm | In distribution |
| ACM1 | In distribution | |
| ACM1 | In distribution | |
| ACM1 | In distribution | |
| CRYO3 | 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 |
| 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 |
|---|---|
| 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.