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) clearance K251247 · decided 2025-08-07
Clearance details
- K-number
- K251247
- 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
- Decision
- Substantially Equivalent
- Date received
- 2025-04-23
- Decision date
- 2025-08-07
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- GXD
- Device class
- 2
- Regulation number
- 882.4400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Valencia, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R) (K242057) | Avanos Medical, Inc. | 2024-08-14 |
| Racz Neurostat RF Generator (K232632) | Epimed International | 2024-05-24 |
| OneRF Ablation System (K231675) | Neuroone Medical Technologies Corp. | 2023-12-06 |
| APEX 6 (K220122) | Rf Innovations, Inc. | 2023-03-15 |
| Abbott Medical Grounding Pad, model RF-DGP-IS (K203293) | ABBOTT MEDICAL | 2022-01-21 |
| IonicRF Generator (K201610) | ABBOTT MEDICAL | 2020-10-21 |
| Coolief Radiofrequency Generator (CRG) System (K192491) | Avanos Medical, Inc. | 2020-02-21 |
| Polaris RF Ablation System (K181864) | Baylis Medical Company, Inc. | 2019-01-02 |
| Relievant Medsystems RF Generator (K171143) | Relievant Medsystems | 2017-08-18 |
| MultiGen™ 2 RF Generator System (K170242) | Stryker Corporation | 2017-05-25 |
| ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEM (K101592) | Cheng Medical, Corporation | 2011-10-06 |
| NT 2000 LESIONING GENERATOR (K111576) | Neuro Therm, Inc. | 2011-09-20 |
Recalls involving this device
No recalls on record reference this clearance.