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510(k) K021144

SUBDURAL STRIP ELECTRODE by Nicolet Biomedical, Inc. — Product Code GYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2002
Date Received
April 9, 2002
Clearance Type
Abbreviated
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 Nicolet Biomedical, Inc.

  • K020754 — NICOLET PIONEER TC8080 (April 21, 2003)
  • K021986 — BRAINET (August 23, 2002)
  • K020218 — SNAP EEG MONITOR (April 22, 2002)
  • K013281 — VERSALAB APM (April 18, 2002)
  • K020955 — NICOLET ELECTROCAUTERY DETECTOR (April 17, 2002)
  • K013419 — NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM (December 20, 2001)
  • K011818 — STERILE EMG ELECTRODES (September 6, 2001)
  • K011823 — BIOREHAB SYSTEM (September 6, 2001)
  • K011135 — GSI AUDERA (July 26, 2001)
  • K010019 — STERILE SUBDERMAL NEEDLE ELECTRODES (March 19, 2001)

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)
  • 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)