GX1 Radiofrequency Generator Kit (RFG-X1-120V) +6 more— 510(k) K251247

Name: FDA 510(k) clearance K251247
Creator: U.S. Food and Drug Administration
Published: 2025-08-07

Substantially Equivalent

Boston Scientific Neuromodulation Corporation

FDA 510(k) clearance K251247 for GX1 Radiofrequency Generator Kit (RFG-X1-120V) +6 more, Substantially Equivalent on 2025-08-07. Applicant: Boston Scientific Neuromodulation Corporation. Device class: 2.

Clearance details

Device name as filed: 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
Product code: Code GXD
Device class: Class 2
Regulation: 21 CFR 882.4400
Advisory panel: Neurology
Date received: 2025-04-23
Decision date: 2025-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valencia, CA, US

Download summary PDF View on FDA.gov ↗

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K242057 — COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)2024-08-14
K232632 — Racz Neurostat RF Generator2024-05-24
K231675 — OneRF Ablation System2023-12-06
K220122 — APEX 62023-03-15
K203293 — Abbott Medical Grounding Pad, model RF-DGP-IS2022-01-21

Adverse events under product code GXD

product code GXD

Injury: 228
Total: 228

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.