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510(k) K222404

Evo® sEEG System by Neuroone Medical Technologies Corp. — Product Code GZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2022
Date Received
August 9, 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 Neuroone Medical Technologies Corp.

  • K251243 — OneRF Trigeminal Nerve Radiofrequency Probes (August 15, 2025)
  • K231675 — OneRF Ablation System (December 6, 2023)
  • K211367 — Evo sEEG System (September 1, 2021)

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)
  • K222706 — iCE-SG2 Subcutaneous Electrode Kit (December 6, 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)