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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Lesion, Radiofrequency
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
25155 Rye Canyon Loop
Valencia,  CA  91355
Applicant Contact Alex Hoang
Correspondent
Boston Scientific Neuromodulation Corporation
25155 Rye Canyon Loop
Valencia,  CA  91355
Correspondent Contact Alex Hoang
Regulation Number882.4400
Classification Product Code
GXD  
Date Received04/23/2025
Decision Date 08/07/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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