Cleared Traditional

K251247 - GX1 Radiofrequency Generator Kit (RFG-X1-120V)

Also marketed or referenced as:
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)

K251247 is an FDA 510(k) clearance for GX1 Radiofrequency Generator Kit (RFG-X..., manufactured by Boston Scientific Neuromodulation Corporation. The device is a Class 2 Neurology device with product code GXD cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K251247 · Boston Scientific Neuromodulation Corporation · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2025
Decision
106d
Days
Class 2
Risk

K251247 is an FDA 510(k) clearance for the GX1 Radiofrequency Generator Kit (RFG-X1-120V). Classified as Generator, Lesion, Radiofrequency (product code GXD), Class II - Special Controls.

Submitted by Boston Scientific Neuromodulation Corporation (Valencia, US). The FDA issued a Cleared decision on August 7, 2025 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4400 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Boston Scientific Neuromodulation Corporation devices

FDA 510(k) Submission Details - K251247

510(k) Number K251247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2025
Decision Date August 07, 2025
Days to Decision 106 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 148d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXD Device Classification - Class 2, Special Controls

Product Code GXD Generator, Lesion, Radiofrequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GXD Generator, Lesion, Radiofrequency

All 30
Devices cleared under the same product code (GXD) and FDA review panel - the closest regulatory comparables to K251247.
COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)
K242057 · Avanos Medical, Inc. · Aug 2024
Racz Neurostat RF Generator
K232632 · Epimed International · May 2024
OneRF Ablation System
K231675 · Neuroone Medical Technologies Corp. · Dec 2023
APEX 6
K220122 · Rf Innovations, Inc. · Mar 2023
Abbott Medical Grounding Pad, model RF-DGP-IS
K203293 · Abbott Medical · Jan 2022
IonicRF Generator
K201610 · Abbott Medical · Oct 2020