GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03)
FDA 510(k) K251247 · Boston Scientific Neuromodulation Corporation
510(k) numberK251247
Submission
- Device name
- GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03)
- Applicant
- Boston Scientific Neuromodulation Corporation
Valencia, CA, US - Received
- April 23, 2025
- Decision date
- August 7, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GXD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242057 | COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)GXD · Special | Avanos Medical, Inc. | 08/14/2024SE |
| K232632 | Racz Neurostat RF GeneratorGXD · Traditional | Epimed International | 05/24/2024SE |
| K231675 | OneRF Ablation SystemGXD · Traditional | Neuroone Medical Technologies Corp. | 12/06/2023SE |
| K220122 | Apex 6GXD · Traditional | Rf Innovations, Inc. | 03/15/2023SE |
| K203293 | Abbott Medical Grounding Pad, model RF-DGP-ISGXD · Traditional | Abbott Medical | 01/21/2022SE |
| K201610 | IonicRF GeneratorGXD · Traditional | Abbott Medical | 10/21/2020SE |
| K192491 | Coolief Radiofrequency Generator (CRG) SystemGXD · Traditional | Avanos Medical, Inc. | 02/21/2020SE |
| K181864 | Polaris RF Ablation SystemGXD · Traditional | Baylis Medical Company, Inc. | 01/02/2019SE |
| K171143 | Relievant Medsystems RF GeneratorGXD · Traditional | Relievant Medsystems | 08/18/2017SE |
| K170242 | MultiGen 2 RF Generator SystemGXD · Traditional | Stryker Corporation | 05/25/2017SE |
More from Stryker Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K233801 | Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System…GZB · Traditional | 08/23/2024SE |
| K232415 | Nalu Neurostimulation System for Peripheral Nerve StimulationGZF · Traditional | 08/21/2024SE |
| K221376 | Nalu Neurostimulation SystemGZB · Special | 06/10/2022SE |
| K203547 | Nalu Neurostimulation SystemGZB · Traditional | 03/25/2021SE |
| K202274 | Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit…GZB · Traditional | 11/09/2020SE |
| K201618 | Nalu Neurostimulation SCS systemGZB · Special | 07/15/2020SE |
| K190960 | Nalu Lead Blank (50cm)GZB · Traditional | 07/11/2019SE |
| K183579 | Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation…GZF · Traditional | 03/29/2019SE |
| K183047 | Nalu Neurostimulation SystemGZB · Traditional | 03/22/2019SE |
Questions and answers
When was GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03) cleared by the FDA?
GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03) (K251247) received a 510(k) decision of Substantially Equivalent on August 7, 2025, 106 days after the submission was received.
What is the product code of K251247?
The FDA product code is GXD – Generator, Lesion, Radiofrequency, a Class II (moderate risk) device regulated under 21 CFR 882.4400.