# GZL: Electrode, Depth

- Device class: 2; regulation: 21 CFR 882.1330; FDA's rule: 510(k) required
- FDA decisions: 58
- 510(k) review time 2021–2025: median 206 days (middle half 105–265)
- Recalls: 18 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2014: 1
- 2016: 2
- 2017: 4
- 2018: 3
- 2020: 1
- 2021: 3
- 2022: 3
- 2023: 3
- 2025: 2
- 2026: 1

## Most-cited predicates
- K964644: AD-Tech's Depth Electrode (1997), cited by 4
- K991077: Microelectroencephalography Professional System 5000 (Eeg Pro System 5000) (1999), cited by 4
- K163355: Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes (2017), cited by 4
- K033173: Micro Targeting Electrode (2004), cited by 4
- K944061: Cueva Cranial Nerve Electrode (1995), cited by 3
- K891920: AD-Tech's Depth Electrode (1989), cited by 3
- K970943: Guideline System (1997), cited by 3
- K170959: DIXI Medical Microdeep Depth Electrode (2017), cited by 3
- K151790: PMT Platinum Depthalon Depth Electrode (2016), cited by 3
- K071364: Microtargeting Guideline 4000 (2007), cited by 2

Source page: https://510kreport.com/product-code/GZL
Data by year (CSV): https://510kreport.com/product-code/GZL.csv