Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Generator, Lesion, Radiofrequency
510(k) Number K260337
Device Name SEEG-Tx® System (STX-SYS-001)
Applicant
Dixi Medical
2a Rte. De Pouligney Chaudefontaine
Marchaux-Chaudefontaine,  FR 25640
Applicant Contact Lucie PETEGNIEF
Correspondent
Medtech Regulatory Strategist, Inc.
538, Daniel Clarke Way
Oakville,  CA
Correspondent Contact Golddy Kaur
Regulation Number882.4400
Classification Product Code
GXD  
Subsequent Product Code
GXI  
Date Received02/02/2026
Decision Date 10/29/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-