Cleared Traditional

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)

K251247 · Boston Scientific Neuromodulation Corporation · Neurology

Aug 2025

Decision

106d

Days

Class 2

Risk

About This 510(k) Submission

K251247 is an FDA 510(k) clearance for the 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), a Generator, Lesion, Radiofrequency (Class II — Special Controls, product code GXD), submitted by Boston Scientific Neuromodulation Corporation (Valencia, US). The FDA issued a Cleared decision on August 7, 2025, 106 days after receiving the submission on April 23, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4400.

Submission Details

510(k) Number	K251247 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 23, 2025
Decision Date	August 07, 2025
Days to Decision	106 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF