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510(k) K191186

Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode by Ad-Tech Medical Instrument Corporation — Product Code GYC

K191186 is an FDA 510(k) premarket notification submitted by Ad-Tech Medical Instrument Corporation for the device "Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode". The FDA issued a decision of Substantially Equivalent on January 25, 2020. The device falls under product code GYC (Electrode, Cortical), a Class II device regulated under 21 CFR 882.1310. Ad-Tech Medical Instrument Corporation has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2020
Date Received
May 3, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cortical
Device Class
Class II
Regulation Number
882.1310
Review Panel
NE
Submission Type

Other clearances by Ad-Tech Medical Instrument Corporation

  • K223269 — Spencer Probe Depth Electrodes (May 18, 2023)
  • K223276 — Anchor Bolts as Accessories to Depth Electrodes (May 18, 2023)
  • K181544 — Anchor Bolt (as an accessory to Depth Electrodes) (August 9, 2018)
  • K170442 — Cranial Drill Bits and Accessories (September 7, 2017)
  • K163355 — Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, S (April 12, 2017)
  • K152769 — FREMAP ELECTRODE (May 6, 2016)
  • K152547 — DNAP Electrode (March 4, 2016)

Other clearances for product code GYC

  • K250094 — Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601 (April 14, 2025)
  • K242618 — Layer 7-T (March 30, 2025)
  • K221123 — WISE Cortical Strip (WCS) (November 22, 2022)
  • K211954 — Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi- (November 10, 2022)
  • K201931 — Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) (October 2, 2021)
  • K191346 — Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) (February 14, 2020)
  • K192764 — NeuroOne Cortical Electrode (November 26, 2019)
  • K183437 — AirRay Subdural Cortical Electrodes (March 12, 2019)
  • K180761 — SD LTM STIM Cortical Stimulator (June 18, 2018)
  • K173684 — g.Estim PRO (May 4, 2018)

FDA data resources