K261442
- 510(k) number
- K261442
- Device name
- Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array
- Applicant
- Cadwell Industries, Inc. WA · US
- Product code
- GXY — Electrode, Cutaneous
- Decision date
- 2026-06-26
- Date received
- 2026-04-30
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K261442.pdf
Official FDA record: K261442
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.