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510(k) K163355

Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes by Ad-Tech Medical Instrument Corporation — Product Code GZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2017
Date Received
November 30, 2016
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 Ad-Tech Medical Instrument Corporation

  • K223276 — Anchor Bolts as Accessories to Depth Electrodes (May 18, 2023)
  • K223269 — Spencer Probe Depth Electrodes (May 18, 2023)
  • K191186 — Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid (January 25, 2020)
  • K181544 — Anchor Bolt (as an accessory to Depth Electrodes) (August 9, 2018)
  • K170442 — Cranial Drill Bits and Accessories (September 7, 2017)
  • K152769 — FREMAP ELECTRODE (May 6, 2016)
  • K152547 — DNAP Electrode (March 4, 2016)

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)
  • K211367 — Evo sEEG System (September 1, 2021)