Product code GYC— Neurology
AD-TECH EPIDURAL PEG ELECTRODE
- Classification name
- Electrode, Cortical
- Device class
- Class 2
- Regulation
- 21 CFR 882.1310
- Advisory panel
- Neurology
- Total cleared
- 32
- First cleared
- Most recent
Market context for product code GYC
FDA has cleared devices under product code GYC between 1985 and 2025, filed by 24 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2025
- 2022
- 2021
- 2020
- 2019
- 2018
- 2016
- 2011
- 2010
- 2009
- 2008
- 2006
- 2002
- 1999
- 1997
Top applicants under product code GYC
Recent clearances under product code GYC
- K250094 — Atlas Stim Headbox (NK) (31-0601-0077) +9 more
- K242618 — Layer 7-T
- K221123 — WISE Cortical Strip (WCS)
- K211954 — Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid
- K201931 — Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)
- K191346 — Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)
- 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
- K192764 — NeuroOne Cortical Electrode
- K183437 — AirRay Subdural Cortical Electrodes
- K180761 — SD LTM STIM Cortical Stimulator
- K173684 — g.Estim PRO
- K151354 — Cervello STIM
- K110410 — MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT)
- K102802 — INTEGRA ELECTRODE TUNNELING NEEDLE
- K082629 — S12X WITH ESAX OPTION
- K082474 — PMT SUBDURAL CORTICAL ELECTRODES
- K072964 — NICOLET CORTICAL STIMULATOR
- K082250 — AURAGEN CORTICAL SURFACE ELECTRODES
- K053363 — DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES
- K021144 — SUBDURAL STRIP ELECTRODE
- K992194 — CORTICAL MAPPING UNIT, MODEL CMU
- K961942 — EPIDURAL PEG ELECTRODE (EP), SPHENOIDAL ELECTRODE (EDS) AND FORAMEN, OVALE DEPTH ELECTRODE (ED-FO) FOR EPILEPSY MONITORI
- K970587 — AD-TECH SUBDURAL ELECTRODE
- K964224 — STAINLESS STEEL CORTAC CORTICAL ELECTRODE(2111)/PLANTINUM CORTAC CORTICAL ELECTRODE
- K926424 — CORTICAL SURF EPILEPSY ELECT DEPTH ELEC EPILEP MON
- K923330 — THE WESTERN CORTICAL ELECTRODE ARRAY
- K924226 — OJEMANN CORTICAL STIMULATOR
- K923803 — AD-TECH SUB DURAL ELECTRODEDS
- K912760 — AD-TECH EPIDURAL PEG ELECTRODE
- K882053 — NICOLET EPIDURAL SPINAL ELECTRODE
- K845035 — ELECTRODE FOR NEUROLOGICAL SURGERY 2111
- K850342 — WYLER SUBDURAL STRIP ELECTRODE
Data sourced from openFDA. This site is unofficial and independent of the FDA.