# K201678: iCE-SG Subcutaneous Electrode Arrays

- Pathway: 510(k) (Traditional)
- Applicant: Ice Neurosystems, Inc.
- Decided: Mar 8, 2021 after 262 days
- Product code: GZL (Electrode, Depth)
- Device class: 2
- Regulation: 21 CFR 882.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K811452 (1981). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163355: Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes, Ad-Tech Medical Instrument Corporation (2017) Summary page 4.
- K961942: Epidural Peg Electrode (EP), Sphenoidal Electrode (Eds) and Foramen, Ovale Depth Electrode (ED-FO) for Epilepsy Monitori, Radionics, Inc. (1997) Summary page 4.

## Most influential descendants
- K222706: iCE-SG2 Subcutaneous Electrode Kit (2022), 0 descendants of its own

## Indications for use
iCE-SG Subcutaneous Electrode Arrays are intended for temporary (<14 days) use with recording and monitoring equipment for the recording and monitoring of electrical signals at the subsurface level of the brain.

Source page: https://510kreport.com/device/K201678
Methodology: https://510kreport.com/methodology