# GXZ: Electrode, Needle

- Device class: 2; regulation: 21 CFR 882.1350; FDA's rule: 510(k) required
- FDA decisions: 53
- 510(k) review time 2021–2025: median 101 days (middle half 61–170)
- Recalls: 21 (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)
- 2010: 1
- 2011: 2
- 2012: 1
- 2013: 2
- 2014: 2
- 2016: 1
- 2019: 2
- 2020: 1
- 2023: 2
- 2024: 1

## Most-cited predicates
- K022914: Rhythmlink International Subdermal Needle Electrodes (2002), cited by 8
- K062996: Disposable Monopolar and Bipolar Stimulator Probes (2007), cited by 7
- K050325: Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar Probe (2005), cited by 4
- K050194: Axon Systems Subdermal Needle Electrodes (2005), cited by 4
- K010019: Sterile Subdermal Needle Electrodes (2001), cited by 3
- K071185: Modification to: Ambu Neuroline, Disposable Monopolar Needle Electrode (2007), cited by 3
- K130136: Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal Needle Electrodes, (2013), cited by 3
- K850107: Concentric Needle Electrodes-Various Sizes W/Conne (1985), cited by 3
- K072276: Subdermal Needle Electrodes (2008), cited by 2
- K063729: Disposable Pedicle Screw Probe, Model 3603-00 (2007), cited by 2

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