Cleared Traditional

SENSOSEEG Depth Electrodes

K213170 · Sensomedical Labs, Ltd. · Neurology
Apr 2023
Decision
567d
Days
Class 2
Risk

About This 510(k) Submission

K213170 is an FDA 510(k) clearance for the SENSOSEEG Depth Electrodes, a Electrode, Depth (Class II — Special Controls, product code GZL), submitted by Sensomedical Labs, Ltd. (Nazareth, IL). The FDA issued a Cleared decision on April 18, 2023, 567 days after receiving the submission on September 28, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1330.

Submission Details

510(k) Number K213170 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2021
Decision Date April 18, 2023
Days to Decision 567 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GZL — Electrode, Depth
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1330

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