Clearance Summary
Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array received FDA 510(k) clearance under submission number K261442, sponsored by Cadwell Industries, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2026-06-26.
- Submission: K261442
- Applicant / Sponsor: Cadwell Industries, Inc.
- Clearance pathway: Abbreviated
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1320
- Decision date: 2026-06-26
Classification & Regulation
This clearance is catalogued under FDA product code GXY and 21 CFR 882.1320, within the Neurology review panel as a Class II device.