GYCClass II

Electrode, Cortical

21 CFR 882.1310 / Neurology

GYC is the FDA product code for Electrode, Cortical, a class II device type, regulated under 21 CFR 882.1310. As of 2026-09-10, FDA records hold 32 510(k) clearances under this code, the most recent dated 2025-04-14, and 6 recalls.

Classification record

Product code: GYC
Device name: Electrode, Cortical
Regulation: 21 CFR 882.1310
Device class: Class II
Review panel: Neurology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 32
Ingested recalls: 6

Clearances, product code GYC

By decision year

32 clearances under product code GYC with a decision year between 1985 and 2025, 1993 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code GYC by decision year
Year	Clearances
1985	2
1988	1
1992	2
1993	3
1997	3
1999	1
2002	1
2006	1
2008	2
2009	2
2010	1
2011	1
2016	1
2018	2
2019	2
2020	2
2021	1
2022	2
2025	2

Applicants with the most clearances

Product code GYC

Applicants holding the most 510(k) clearances under product code GYC
Applicant	Clearances
AD-Tech Medical Instrument Corp.	7
Radionics, Inc.	3
PMT Corp.	2
Blackrock Microsystems	1
Blackrock Neuromed	1
Medtronic, Inc.	1
Chatten Associates, Inc.	1
Cortec GmbH	1
Dixi Medical	1
G.tec Medical Engineering GmbH	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 29 companies shown, in name order