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GX1 Radiofrequency Generator Kit (RFG-X1-120V) +6 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K251247

by Boston Scientific Neuromodulation Corporation

Identifiers

510(k) Number
K251247 FDA 510(k)
FDA Product Code
GXD FDA 510(k)
Models / Variants
GX1 Radiofrequency Generator Kit (RFG-X1-120V) FDA 510(k)
GX1 Radiofrequency Generator Kit (RFG-X1-220V) FDA 510(k)
GX1 Radiofrequency Generator Kit (RFG-X1-240V) FDA 510(k)
GX1 System Release Rest of World (GX1-SYS-ROW) FDA 510(k)
GX1 Radiofrequency Generator (51779845-01) FDA 510(k)
GX1 Radiofrequency Generator (51779845-02) FDA 510(k)
GX1 Radiofrequency Generator (51779845-03) FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.4400 FDA 510(k)
Regulation Number
882.4400 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

GX1 Radiofrequency Generator Kit (RFG-X1-120V) +6 more models by Boston Scientific Neuromodulation Corporation — Class II — FDA_510K — listed in FDA 510(k)…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Boston Scientific Neuromodulation Corporation

Sources (1)

  • FDA 510(k) K251247 24 fields · synced Jun 18, 2026