Coolief* Cooled RF Advanced-R Generator
COOLIEF* Cooled RF Advanced-R Generator, QTY 1
2manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Guangdong (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Cathay Manufacturing Corp. | Shanghai | Shanghai | Contract manufacturer | 5 |
Record
| Listed by | Avanos Medical, Inc., United States |
|---|---|
| FDA product code | GXD |
| Device type | Generator, Lesion, Radiofrequency |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4400 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K192491 |
| Record published | 2021-01-27 |
| Record revised | 2023-06-22 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CRG-ADVANCED-R | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Generator, Lesion, Radiofrequency | Boston Scientific Neuromodulation Corporation | 68 |
| Generator, Lesion, Radiofrequency | Stryker Leibinger Gmbh & Co. KG | 58 |
| OneRF Ablation System | Neuroone Medical Technologies Corp. | 7 |
| GX1™ | Boston Scientific Neuromodulation Corporation | 7 |
| Accurian | Medtronic Sofamor Danek, Inc. | 7 |
| Multigen 2 | Stryker GmbH | 6 |
| Avanos* | Avanos Medical, Inc. | 4 |
| OWL | Diros Technology, Inc. | 4 |
| NeuroTherm™ | Neurotherm, Inc. | 3 |
| Halyard | Avanos Medical, Inc. | 3 |
| Venom Multigen 2 | Stryker GmbH | 2 |
| Relievant | Relievant Medsystems | 2 |
Showing 12 of 26. All products under Generator, Lesion, Radiofrequency
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242057 | 2024-08-14 |
| K192491 | 2020-02-21 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Avanos Medical, Inc. | 510(k) number | 2023-08-01 | Class II | Process change control | Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults. | 24 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.