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510(k) K191346

Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) by Blackrock Microsystems — Product Code GYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2020
Date Received
May 20, 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 Blackrock Microsystems

  • K202174 — Digital NeuroPort Biopotential Signal Processing System (February 10, 2021)
  • K110010 — NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM (February 9, 2011)

Other clearances for product code GYC

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  • 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)
  • K191186 — Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid (January 25, 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)