# K970587: AD-Tech Subdural Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Ad-Tech Medical Instrument Corp
- Decided: May 9, 1997 after 80 days
- Product code: GYC (Electrode, Cortical)
- Device class: 2
- Regulation: 21 CFR 882.1310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 2 cite it directly.
1 of 12 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K021144: Subdural Strip Electrode (2002), 10 descendants of its own
- K053363: Dual-Sided Interhemispheric Subdural Electrodes, Grid Subdural Electrodes, Intraoperative Subdural Electrodes (2006), 9 descendants of its own
- 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

Source page: https://510kreport.com/device/K970587
Methodology: https://510kreport.com/methodology