# K170959: DIXI Medical Microdeep Depth Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Dixi Medical
- Decided: Nov 24, 2017 after 238 days
- Product code: GZL (Electrode, Depth)
- Device class: 2
- Regulation: 21 CFR 882.1330
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K811452 (1981). 17 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151790: PMT Platinum Depthalon Depth Electrode, Pmt Corporation (2016) Summary page 5.
- K053358: Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth Electrodes, Ad-Tech Medical Instrument Corp (2006) Summary page 5.
- K012850: Recording and Stimulating Electrode, Radionics, A Division of Tyco Healthcare Group LP (2001) Summary page 5.

## Most influential descendants
- K211367: Evo sEEG System (2021), 2 descendants of its own
- K213170: SENSOSEEG Depth Electrodes (2023), 1 descendant of its own
- K222404: Evo® sEEG System (2022), 1 descendant of its own
- K253970: Wovyn Depth Electrode (2026), 0 descendants of its own
- K250363: Depth Electrode (RSDE-08);  Depth Electrode (RSDE-10);  Depth Electrode (RSDE-12);  Depth Electrode (RSDE-14);  Depth Electrode (RSDE-16);  Depth Electrode (RSDE-16F);  Depth Electrode (RSDE-08S);  Depth Electrode (RSDE-10S);  Depth Electrode (RSDE-12S);  Depth Electrode (RSDE-14S);  Depth Electrode (RSDE-16S);  Depth Electrode (RSDE-16G);  Depth Electrode (RSDE-18);  Depth Electrode (RSDE-18F);  Depth Electrode (RSDE-18T);  Depth Electrode (RSDE-20);  Depth Electrode (RSDE-20F);  Dept (2025), 0 descendants of its own

## Recalls of this device
- Dec 9, 2021 · Class II · Z-0535-2022: Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
- Dec 9, 2021 · Class II · Z-0536-2022: Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
- Dec 9, 2021 · Class II · Z-0538-2022: Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
- Dec 9, 2021 · Class II · Z-0539-2022: Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
- Dec 9, 2021 · Class II · Z-0537-2022: Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
- Dec 9, 2021 · Class II · Z-0541-2022: Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
- Dec 9, 2021 · Class II · Z-0542-2022: Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
- Dec 9, 2021 · Class II · Z-0540-2022: Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
- Dec 9, 2021 · Class II · Z-0534-2022: Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag

## Indications for use
The DIXI Medical Microdeep Depth Electrodes are intended for temporary (<30 day) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain.

Source page: https://510kreport.com/device/K170959
Methodology: https://510kreport.com/methodology