K251247

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)

510(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 CA · US
Product code: GXD — Generator, Lesion, Radiofrequency
Decision date: 2025-08-07
Date received: 2025-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Neurology

PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain

Also available from FDA: K251247.pdf

Official FDA record: K251247

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.