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510(k) K222706

iCE-SG2 Subcutaneous Electrode Kit by Ice Neurosystems, Inc. — Product Code GZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2022
Date Received
September 7, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Depth
Device Class
Class II
Regulation Number
882.1330
Review Panel
NE
Submission Type

Other clearances by Ice Neurosystems, Inc.

  • K201678 — iCE-SG Subcutaneous Electrode Arrays (March 8, 2021)
  • K191868 — iCEWav Neuromonitoring Platform (March 31, 2020)

Other clearances for product code GZL

  • K250363 — Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12 (November 5, 2025)
  • K250601 — Neuro Omega System; NeuroSmart System (March 30, 2025)
  • K223269 — Spencer Probe Depth Electrodes (May 18, 2023)
  • K223276 — Anchor Bolts as Accessories to Depth Electrodes (May 18, 2023)
  • K213170 — SENSOSEEG Depth Electrodes (April 18, 2023)
  • K222404 — Evo® sEEG System (October 20, 2022)
  • K220553 — Neuro Omega System, NeuroSmart System (September 16, 2022)
  • K202087 — DIXI Medical Microdeep Micro-Macro Depth Electrodes (November 18, 2021)
  • K211367 — Evo sEEG System (September 1, 2021)
  • K201678 — iCE-SG Subcutaneous Electrode Arrays (March 8, 2021)