# GXD: Generator, Lesion, Radiofrequency

- Device class: 2; regulation: 21 CFR 882.4400; FDA's rule: 510(k) required
- FDA decisions: 37
- 510(k) review time 2021–2025: median 225 days (middle half 125–383)
- 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)
- 2008: 2
- 2010: 1
- 2011: 2
- 2017: 2
- 2019: 1
- 2020: 2
- 2022: 1
- 2023: 2
- 2024: 2
- 2025: 1

## Most-cited predicates
- K010202: Owl Radiofrequency System, Model Urf-2A, and Associate Radiofrequency Lesion Probes (2001), cited by 7
- K963577: Radionics Sluijter-Mehta Cannula (1996), cited by 6
- K052878: NT-1000 (2006), cited by 6
- K982489: RFG-3C Plus (1998), cited by 4
- K082051: Cosman G4 Radiofrequency Generator, Model RFG-4 (2008), cited by 3
- K965182: RFG-3CF (1997), cited by 3
- K111576: NT 2000 Lesioning Generator (2011), cited by 3
- K896450: Neuro N 50 Lesion Generator (1991), cited by 2
- K021869: Owl Radiofrequency System, Model Urf-2AP (2002), cited by 2
- K071482: Stryker RF Multi-Lesion Generator, Model 0406-900-000 (2007), cited by 2

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