Cleared Traditional

K260337 - SEEG-Tx® System (STX-SYS-001)

K260337 is an FDA 510(k) clearance for SEEG-Tx System (STX-SYS-001), manufactured by Dixi Medical. The device is a Class 2 Neurology device with product code GXD cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K260337 · Dixi Medical · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
269d
Days
Class 2
Risk

K260337 is an FDA 510(k) clearance for the SEEG-Tx® System (STX-SYS-001). Classified as Generator, Lesion, Radiofrequency (product code GXD), Class II - Special Controls.

Submitted by Dixi Medical (Marchaux-Chaudefontaine, FR). The FDA issued a Cleared decision on October 29, 2026 after a review of 269 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K260337

510(k) Number K260337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2026
Decision Date October 29, 2026
Days to Decision 269 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
120d slower than avg
Panel avg: 149d · This submission: 269d
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 Consultant

Medtech Regulatory Strategist, Inc.
Golddy Kaur

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GXD Generator, Lesion, Radiofrequency

All 37
Devices cleared under the same product code (GXD) and FDA review panel - the closest regulatory comparables to K260337.
GX1 Radiofrequency Generator Kit (RFG-X1-120V)
K251247 · Boston Scientific Neuromodulation Corporation · Aug 2025
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
K260337 · SEEG-Tx® System (STX-SYS-001)
Download PDF FDA Summary Dixi Medical