Multigen 2
200MM Electrode
2manufacturers in China registered for this device type
6catalogue numbers in this listing
1510(k) clearance
2recalls on this code
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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | GXD |
| Device type | Generator, Lesion, Radiofrequency |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4400 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2017-06-15 |
| Record revised | 2024-05-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -34 to 65 °C |
| Sizes | Length 50 to 200 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8400-815-020 | Length 200.0 mm | In distribution |
| 8400-815-010 | Length 100.0 mm | In distribution |
| 8400-815-005 | Length 50.0 mm | In distribution |
| 8400-815-015 | Length 150.0 mm | In distribution |
| 8400-800-000 | In distribution | |
| 8400-000-000 | 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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K170242 | 2017-05-25 |
Recalls
1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-10-11 | Class III | Labeling Change Control | Stryker Instruments is voluntarily recalling the Care Instructions/Instructions for Use packaged with the Radiofrequency (RF) MultiGen Generator, because the instructions for use incorrectly contained instructions supporting the sterilizati | 2,675 | 2017-07-25 |
| 2010-04-13 | Not classified | Component design/selection | This recall is related to the Electri-cord recall. There is a risk when excessive force is applied to the plugs, a fracture can develop on the prongs inside the molded section of the plug. Over time the fracture may lead to arcing inside o | 3364 all products | 2011-05-16 |
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.