Clearance Summary
X-trodes System M received FDA 510(k) clearance under submission number K232210, sponsored by X-Trodes. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2024-02-04.
- Submission: K232210
- Applicant / Sponsor: X-Trodes
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1835
- Decision date: 2024-02-04
Classification & Regulation
This clearance is catalogued under FDA product code GWL and 21 CFR 882.1835, within the Neurology review panel as a Class II device.