Clearance Summary
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) received FDA 510(k) clearance under submission number K251247, sponsored by Boston Scientific Neuromodulation Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2025-08-07.
- Submission: K251247
- Applicant / Sponsor: Boston Scientific Neuromodulation Corporation
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4400
- Decision date: 2025-08-07
Classification & Regulation
This clearance is catalogued under FDA product code GXD and 21 CFR 882.4400, within the Neurology review panel as a Class II device.