Cleared Traditional

Delphi MCS Electrode Cap

K243243 · Quantalx Neuroscience, Ltd. · Neurology

Feb 2025

Decision

118d

Days

Class 2

Risk

About This 510(k) Submission

K243243 is an FDA 510(k) clearance for the Delphi MCS Electrode Cap, a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Quantalx Neuroscience, Ltd. (Kfar Sava, IL). The FDA issued a Cleared decision on February 6, 2025, 118 days after receiving the submission on October 11, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number	K243243 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 11, 2024
Decision Date	February 06, 2025
Days to Decision	118 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF