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510(k) K923803

AD-TECH SUB DURAL ELECTRODEDS by Ad-Tech Medical Instrument Corp — Product Code GYC

K923803 is an FDA 510(k) premarket notification submitted by Ad-Tech Medical Instrument Corp for the device "AD-TECH SUB DURAL ELECTRODEDS". The FDA issued a decision of Substantially Equivalent on October 23, 1992. The device falls under product code GYC (Electrode, Cortical), a Class II device regulated under 21 CFR 882.1310. Ad-Tech Medical Instrument Corp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1992
Date Received
July 29, 1992
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 Corp

  • K112094 — BRAIN BIOPSY NEEDLE (April 24, 2012)
  • K053363 — DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRA (May 30, 2006)
  • K053358 — DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTROD (May 25, 2006)
  • K041604 — MACRO-MICRO DEPTH ELECTRODE (August 16, 2004)
  • K990788 — AD-TECH'S FORAMEN OVALE ELECTRODE (November 2, 1999)
  • K992194 — CORTICAL MAPPING UNIT, MODEL CMU (September 13, 1999)
  • K973454 — AD-TECH'S SPINAL ELECTRODE (June 10, 1998)
  • K970587 — AD-TECH SUBDURAL ELECTRODE (May 9, 1997)
  • K964644 — AD-TECH'S DEPTH ELECTRODE (May 9, 1997)
  • K940320 — AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS (September 19, 1995)

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)

FDA data resources