GXD — Generator, Lesion, Radiofrequency Class II
FDA product code GXD covers "Generator, Lesion, Radiofrequency", a Class II medical device regulated under 21 CFR 882.4400. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GXD
- Device Class
- Class II
- Regulation Number
- 882.4400
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251247 | boston scientific neuromodulation corporation | GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit | August 7, 2025 |
| K242057 | avanos medical | COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADV | August 14, 2024 |
| K232632 | epimed international | Racz Neurostat RF Generator | May 24, 2024 |
| K231675 | neuroone medical technologies | OneRF Ablation System | December 6, 2023 |
| K220122 | rf innovations | APEX 6 | March 15, 2023 |
| K203293 | abbott medical | Abbott Medical Grounding Pad, model RF-DGP-IS | January 21, 2022 |
| K201610 | abbott medical | IonicRF Generator | October 21, 2020 |
| K192491 | avanos medical | Coolief Radiofrequency Generator (CRG) System | February 21, 2020 |
| K181864 | baylis medical company | Polaris RF Ablation System | January 2, 2019 |
| K171143 | relievant medsystems | Relievant Medsystems RF Generator | August 18, 2017 |
| K170242 | stryker corporation | MultiGen 2 RF Generator System | May 25, 2017 |
| K101592 | cheng medical, corporation | ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEM | October 6, 2011 |
| K111576 | neuro therm | NT 2000 LESIONING GENERATOR | September 20, 2011 |
| K093185 | diros technology | OWL UNIVERSAL RF SYSTEM URF-3AP (ML) | January 22, 2010 |
| K082051 | cosman medical | COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4 | October 16, 2008 |
| K081729 | bioform medical | MODIFICATION TO GFX NERVE ABLATION SYSTEM | August 7, 2008 |
| K071482 | synergetics | STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000 | December 20, 2007 |
| K063753 | aci | GFX NERVE ABLATION SYSTEM | June 20, 2007 |
| K070336 | stockert | STOCKERT NEURO N50, MODEL12267 | June 14, 2007 |
| K063489 | synergetics | STRYKER INTRADISCAL RF GENERATOR | May 23, 2007 |