Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array— 510(k) K261442
Substantially EquivalentCadwell Industries, Inc.
FDA 510(k) clearance K261442 for Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array, Substantially Equivalent on 2026-06-26. Applicant: Cadwell Industries, Inc.. Device class: 2.
Summary
Cadwell Industries' clearance covers two Charlotte ACC25 Surface Electrode Arrays, one of them named as reusable. They're filed under GXY, cutaneous electrodes, and the record doesn't describe them beyond their names and the code name.
Class II, 21 CFR 882.1320. Neurology is both the classification panel and the review panel. The submission was an Abbreviated 510(k).
Cadwell filed from Kennewick, Washington. Review took 57 calendar days (April 30 to June 26, 2026).
Clearance details
- Applicant
- Cadwell Industries, Inc.
- Product code
- Product code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Kennewick, WA, US
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