iCE-SG Subcutaneous Electrode Arrays— 510(k) K201678

Name: FDA 510(k) clearance K201678
Creator: U.S. Food and Drug Administration
Published: 2021-03-08

Substantially Equivalent

Ice Neurosystems, Inc.

FDA 510(k) clearance K201678 for iCE-SG Subcutaneous Electrode Arrays, Substantially Equivalent on 2021-03-08. Applicant: Ice Neurosystems, Inc.. Device class: 2.

Clearance details

Applicant: Ice Neurosystems, Inc.
Product code: Code GZL
Device class: Class 2
Regulation: 21 CFR 882.1330
Advisory panel: Neurology
Date received: 2020-06-19
Decision date: 2021-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GZL

view all

K253970 — Wovyn Depth Electrode2026-04-17
K250363 — Depth Electrode (17+ models)2025-11-05
K250601 — Neuro Omega System; NeuroSmart System2025-03-30
K223269 — Spencer Probe Depth Electrodes2023-05-18
K223276 — Anchor Bolts as Accessories to Depth Electrodes2023-05-18

More clearances from Ice Neurosystems, Inc.

view all

K222706 — iCE-SG2 Subcutaneous Electrode Kit2022-12-06
K191868 — iCEWav Neuromonitoring Platform2020-03-31

Data sourced from openFDA. This site is unofficial and independent of the FDA.