# GXI: Probe, Radiofrequency Lesion

- Device class: 2; regulation: 21 CFR 882.4725; FDA's rule: 510(k) required
- FDA decisions: 66
- 510(k) review time 2021–2025: median 113 days (middle half 97–216)
- Recalls: 12 (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
- 2015: 1
- 2016: 3
- 2017: 3
- 2018: 1
- 2019: 3
- 2020: 3
- 2022: 2
- 2025: 4
- 2026: 2

## Most-cited predicates
- K001588: Arthrocare System 2000 Controller, Arthrocare System 2000 Cable, Arthrocare System 2000 Footswitch, Arthrocare System 20 (2000), cited by 8
- K870028: SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible (1987), cited by 8
- K980430: Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) (1998), cited by 7
- K050084: Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal Electrode Kit; Cosman Tic Trigeminal Electrode Kit; (2005), cited by 6
- K060799: Cosman CSK RF Cannula; Cosman RFK RF Cannula (2006), cited by 5
- K042375: SMK, CX, Cxe, RCN (2004), cited by 4
- K002389: Baylis Pain Management Probe/PMP-20-145 and Baylis Pain Management Connector Cable/PMX-Bay-Bay (2000), cited by 4
- K972846: BMC RF Cannula (1998), cited by 4
- K994344: Neurotherm RF Cannula (2000), cited by 4
- K053082: Baylis Pain Management Cooled Probe, Model PMPC-18-150-6 (2005), cited by 4

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