FDA 510(k)

Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array

Número K: K261442 · 2026-06-26

Data da decisão2026-06-26

Código do produtoGXY

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array is the device name listed in this FDA 510(k) record. The listed applicant is Cadwell Industries, Inc.. It received FDA 510(k) clearance on 2026-06-26 under 510(k) number K261442. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array?

Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array is a medical device that received FDA 510(k) clearance on 2026-06-26. The listed applicant is Cadwell Industries, Inc.. The 510(k) number is K261442.

When did Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array receive FDA 510(k) clearance?

Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array received FDA 510(k) clearance on 2026-06-26, under 510(k) number K261442.

Who is the listed applicant for Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array?

The FDA 510(k) record lists Cadwell Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array?

The FDA product code for Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array is GXY.

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Fonte oficial

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