Cleared Traditional

X-trodes System M

K232210 · X-Trodes · Neurology
Feb 2024
Decision
193d
Days
Class 2
Risk

About This 510(k) Submission

K232210 is an FDA 510(k) clearance for the X-trodes System M, a Amplifier, Physiological Signal (Class II — Special Controls, product code GWL), submitted by X-Trodes (Herzeliya, IL). The FDA issued a Cleared decision on February 4, 2024, 193 days after receiving the submission on July 26, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1835.

Submission Details

510(k) Number K232210 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 2023
Decision Date February 04, 2024
Days to Decision 193 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWL — Amplifier, Physiological Signal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1835