Generator, Lesion, Radiofrequency
Regulation 882.4400
0510(k)s in 12 months (37 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in GXD
| Company | 510(k)s | Recalls |
|---|---|---|
| Radionics, Inc. | 4 | 0 |
| ABBOTT MEDICAL | 2 | 1 |
| Avanos Medical, Inc. | 2 | 1 |
| Baylis Medical Co., Inc. | 3 | 0 |
| Diros Technology, Inc. | 3 | 0 |
| Neuro Therm, Inc. | 2 | 0 |
| Stryker Instruments Div. of Stryker Corporation | 0 | 2 |
| Synergetics, Inc. | 2 | 0 |
| Abbott | 0 | 1 |
| Abbott Laboratories Inc. (St Jude Medical) | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 2, 2023 | Abbott Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator Open, Classified |
GXD | K111576 |
| Sep 21, 2023 | Avanos Medical, Inc. COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF channels to be activated individually or altogether. The system is controlled via a Completed |
GXD | K192491 |
| Apr 22, 2021 | Abbott Laboratories Inc. (St Jude Medical) NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000 Terminated |
GXD | K111576 |
| Oct 14, 2019 | Abbott Medical Radiofrequency Grounding Pad, REF RF-DGP-L Terminated |
GXD | K111576 |
| Nov 16, 2016 | Stryker Instruments Div. of Stryker Corporation RF MultiGen, 0406-900-000; Refurb RF MultiGen, 0406-900-000U Terminated |
GXD | K071482 |
| Apr 9, 2016 | Neurotherm, Inc. Neurotherm NT2000iX RF Generator
Model Number: RFG-NT -2000iX Terminated |
GXD | K111576 |
| Jan 18, 2011 | Stryker Instruments Div. of Stryker Corporation Stryker Instruments, Interventional Spine RF MultiGen REF 0406-900-000, Rx only,, Stryker Instruments, Kalamazoo, MI (USA), 49001, (269) 323-7700, (800) 253-3210.
The product is intended for coagulati Terminated |
GXD | K032601 |
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