# K053363: Dual-Sided Interhemispheric Subdural Electrodes, Grid Subdural Electrodes, Intraoperative Subdural Electrodes

- Pathway: 510(k) (Abbreviated)
- Applicant: Ad-Tech Medical Instrument Corp
- Decided: May 30, 2006 after 179 days
- Product code: GYC (Electrode, Cortical)
- Device class: 2
- Regulation: 21 CFR 882.1310
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K850342 (1985). 4 ancestors in all.
9 later devices descend from it; 5 cite it directly.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970587: AD-Tech Subdural Electrode, Ad-Tech Medical Instrument Corp (1997) Summary page 1.
- K923803: AD-Tech Sub Dural Electrodeds, Ad-Tech Medical Instrument Corp (1992) Summary page 1.
- K021144: Subdural Strip Electrode, Nicolet Biomedical, Inc. (2002) Summary page 1.

## Most influential descendants
- 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 (2020), 4 descendants of its own
- K082474: PMT Subdural Cortical Electrodes (2009), 1 descendant of its own
- K242618: Layer 7-T (2025), 0 descendants of its own
- K221123: WISE Cortical Strip (WCS) (2022), 0 descendants of its own
- K211954: Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid (2022), 0 descendants of its own

## Recalls of this device
- Jun 18, 2019 · Class II · Z-2406-2019: Supplemental information provided with devices indicates that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which they are not approved fo
- Dec 18, 2012 · Class I · Z-0892-2013: The microelectrodes are not flush with the silastic substrate, may contain sharp edges capable of abrading the cortical surface, and may have remaining pieces which may fracture and remain in the cort

## Indications for use
The AD-TECH Subdural Electrodes (Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler) are intended for temporary (< 30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals on the surface of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.

Source page: https://510kreport.com/device/K053363
Methodology: https://510kreport.com/methodology