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510(k) K211367

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 2021
Date Received
May 4, 2021
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)
  • K222404 — Evo® sEEG System (October 20, 2022)

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)
  • K223276 — Anchor Bolts as Accessories to Depth Electrodes (May 18, 2023)
  • K223269 — Spencer Probe Depth Electrodes (May 18, 2023)
  • K213170 — SENSOSEEG Depth Electrodes (April 18, 2023)
  • K222706 — iCE-SG2 Subcutaneous Electrode Kit (December 6, 2022)
  • 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)
  • K201678 — iCE-SG Subcutaneous Electrode Arrays (March 8, 2021)