510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K251247Substantially Equivalent

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)

Boston Scientific Neuromodulation Corporation, Valencia CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K251247 is the FDA 510(k) clearance record for 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 class II device, cleared for Boston Scientific Neuromodulation Corporation on under FDA product code GXD (Generator, Lesion, Radiofrequency). FDA records list 16 510(k) clearances for Boston Scientific Neuromodulation Corporation, from to . As of , FDA records show no recalls naming K251247.

Clearance record

Decision date
Received
(106 days to decision)
Product code
GXD Generator, Lesion, Radiofrequency
Regulation
21 CFR 882.4400
Device class
Class II
Review panel
Neurology
Applicant
Boston Scientific Neuromodulation Corporation 25155 Rye Canyon Loop, Valencia CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GXD

Trailing 12 months

FDA records hold no clearances under product code GXD in the trailing twelve months.

FDA records show no clearances under product code GXD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GXD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260