GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Gener
Summary
Boston Scientific Neuromodulation Corporation received 510(k) clearance 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 GXD device. Cleared on 2025-08-07.
Details
Source
510(k) Clearance
External ID
K251247
Action Date
2025-08-07
Status
Traditional
Category
device
Product Code
GXD
Product Description
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). Product code: GXD.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month.
Boston Scientific Neuromodulation Corporation has 11 FDA actions in our database, including 10 recalls and 1 clearance.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Boston Scientific Neuromodulation Corporation have FDA actions?
Boston Scientific Neuromodulation Corporation has 11 FDA actions in our database, including 10 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K251247" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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