# GZB: Stimulator, Spinal-Cord, Implanted (Pain Relief)

- Device class: 2; regulation: 21 CFR 882.5880; FDA's rule: 510(k) required
- FDA decisions: 139
- 510(k) review time 2021–2025: median 111 days (middle half 70–190)
- Recalls: 4 (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: 2
- 2015: 2
- 2016: 2
- 2017: 2
- 2018: 1
- 2019: 4
- 2020: 2
- 2021: 1
- 2022: 1
- 2024: 1

## Most-cited predicates
- K141399: Freedom Spinal Cord Stimulator (SCS) System (2014), cited by 5
- K934065: Medtronic Mattrix 3271/3272 Neurostimulation System (1995), cited by 5
- K923567: Medtronic Model 3888 Pisces-Quad Plus Lead (1992), cited by 3
- K111462: Fixate Tissue Band (2011), cited by 3
- K170141: Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit (2017), cited by 3
- K923931: Medtronic Model 3487A Pisces-Quad Lead (1993), cited by 3
- K183047: Nalu Neurostimulation System (2019), cited by 3
- K883780: Xtrel, Model Number 3425 (1988), cited by 3
- K150517: Freedom Spinal Cord Stimulator System (2015), cited by 3
- K913993: Medtronic Models 3982 a,B,C&D Stag Array Res Leads (1992), cited by 2

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