510(k) K251247
- Device
- 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
- 510(k) number
- K251247
- Product code
- GXD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-08-07
- Date received
- 2025-04-23
- Regulation
- 882.4400
- Classification name
- Generator, Lesion, Radiofrequency
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Alex Hoang
- Address
- 25155 Rye Canyon Loop Valencia CA US 91355 91355
FDA Registration Numbers
- 9680425
- 3015173212
- 3015967359
- 3003120897
- 1000632857
- 2183744
- 3016678045
- 1627487
- 3007695959
- 2182269
- 3011270181
- 9616693
- 2184149
- 9680001
- 3030733800
- 1643059
- 2954783
- 8043398
- 3010653929
- 3016438686
- 3003477135
- 3010966701
- 3009555600
- 2124215
- 1030489
- 1316297
- 3020968442
- 3007029079
- 8010177
- 1721676
- 1644312
- 3009766315
- 3007997036
- 3005941719
- 3007221462
- 3018094310
- 3001592626
- 1224960
- 3010126772
- 2133786
- 3008837339
- 3006630150
- 1721983
- 1319639
- 3005160949
- 3005334138
- 1928237
- 9611612
- 3043527620
- 2183613
Source Documents
Other 510(k) Records For Product Code GXD
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242057 | COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R) | Avanos Medical, Inc. | 2024-08-14 |
| K232632 | Racz Neurostat RF Generator | Epimed International | 2024-05-24 |
| K231675 | OneRF Ablation System | Neuroone Medical Technologies Corp. | 2023-12-06 |
| K220122 | APEX 6 | Rf Innovations, Inc. | 2023-03-15 |
| K203293 | Abbott Medical Grounding Pad, model RF-DGP-IS | ABBOTT MEDICAL | 2022-01-21 |
| K201610 | IonicRF Generator | ABBOTT MEDICAL | 2020-10-21 |
| K192491 | Coolief Radiofrequency Generator (CRG) System | Avanos Medical, Inc. | 2020-02-21 |
| K181864 | Polaris RF Ablation System | Baylis Medical Company, Inc. | 2019-01-02 |
| K171143 | Relievant Medsystems RF Generator | Relievant Medsystems | 2017-08-18 |
| K170242 | MultiGen™ 2 RF Generator System | Stryker Corporation | 2017-05-25 |
| K101592 | ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEM | Cheng Medical, Corporation | 2011-10-06 |
| K111576 | NT 2000 LESIONING GENERATOR | Neuro Therm, Inc. | 2011-09-20 |
| K093185 | OWL UNIVERSAL RF SYSTEM URF-3AP (ML) | Diros Technology, Inc. | 2010-01-22 |
| K082051 | COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4 | Cosman Medical, Inc. | 2008-10-16 |
| K081729 | MODIFICATION TO GFX NERVE ABLATION SYSTEM | Bioform Medical, Inc. | 2008-08-07 |