510(k) clearance
SEEG-Tx® System (STX-SYS-001)
- 510(k) number
- K260337
- Applicant
- Dixi Medical
- Decision date
- Oct 29, 2026
- Date received
- Feb 2, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- GXD
- Device type
- Generator, Lesion, Radiofrequency
- Device class
- Class II
- Regulation
- 21 CFR 882.4400
- Advisory committee
- Neurology
- Statement or summary
- Summary
- Third party
- N
- Location
- Marchaux-Chaudefontaine, FR