Accurian
Generator AG1000 RF Generator W/Stand
2manufacturers in China registered for this device type
7catalogue numbers in this listing
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 | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | GXD |
| Device type | Generator, Lesion, Radiofrequency |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4400 |
| 510(k) | K181864 |
| Record published | 2019-03-29 |
| Record revised | 2024-05-16 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Storage | Special storage condition: Store between -20°C and 60°C, Rel. Humidity 20% – 95% non-condensing |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AP1000 | In distribution | |
| AG1000 | In distribution | |
| AGSW001 | In distribution | |
| APH100 | In distribution | |
| ASP001 | In distribution | |
| APH200 | In distribution | |
| ASG001 | 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 |
| 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 |
| IonicRF™ | St. Jude Medical | 2 |
Showing 12 of 26. All products under Generator, Lesion, Radiofrequency
Recalls Naming This Product
5 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2020-06-08 | Class II | Under Investigation by firm | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. | 481 pk | 2022-05-10 |
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2020-06-08 | Class II | Under Investigation by firm | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. | 2415 pk | 2022-05-10 |
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2020-06-08 | Class II | Under Investigation by firm | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. | 352 pk | 2022-05-10 |
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2020-06-08 | Class II | Under Investigation by firm | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. | 5 pk | 2022-05-10 |
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2020-06-08 | Class II | Under Investigation by firm | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. | 25 pk | 2022-05-10 |
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.