# K082629: S12X with Esax Option

- Pathway: 510(k) (Traditional)
- Applicant: Chatten Associates, Inc.
- Decided: Jul 1, 2009 after 295 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
Longest line of descent: 3 generations back to K944678 (1995). 5 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924226: Ojemann Cortical Stimulator, Radionics, Inc. (1993) Summary page 1.
- K040360: EMU128S, Model EX-NW-128S, Excel Tech., Ltd. (2004) Summary page 1.
- K073491: Eeg-1100A Switch Box, Nihon Kohden America, Inc. (2008) Summary page 1.
- (no number) S12 Cortical Stimulator: named in the summary without a submission number

## Most influential descendants
- K151354: Cervello STIM (2016), 2 descendants of its own
- K180761: SD LTM STIM Cortical Stimulator (2018), 1 descendant of its own
- K250094: Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014) (2025), 0 descendants of its own
- K173684: g.Estim PRO (2018), 0 descendants of its own

## Indications for use
The S12X Cortical Stimulator is intended for Intraoperative cortical stimulation mapping to aid in cortical resections in the vicinity of essential cortex. The device is intended for use only by medically trained and qualified personnel, within a hospital or medical environment. The ESAx option is intended for use with the S12X for facilitating the switching of the patient electrodes.

Source page: https://510kreport.com/device/K082629
Methodology: https://510kreport.com/methodology