# GXH: Device, Surgical, Cryogenic

- Device class: 2; regulation: 21 CFR 882.4250; FDA's rule: 510(k) required
- FDA decisions: 23
- 510(k) review time 2021–2025: median 44 days (middle half 29–70)
- Recalls: 0 (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: 1
- 2017: 1
- 2018: 3
- 2020: 1
- 2021: 1
- 2022: 1
- 2023: 1
- 2024: 2
- 2025: 1

## Most-cited predicates
- K854334: Painblocker WA5000 (1986), cited by 3
- K142203: Atricure Cryo Module System; cryoICE cryoablation probe (2014), cited by 3
- K180138: AtriCure cryoICE cryo-ablation probe (CRYO2) (2018), cited by 2
- K831963: Cryomedics Neurostat (1983), cited by 2
- K031482: Cryostar System, Comprising: a) Cryostar Console, B) Cryostar 1MM Cryoprobe, C) Cryostar 2MM Cryoprobe, D) Convenience (2003), cited by 2
- K781302: Neurostat, Lloyd (1978), cited by 2
- K200697: AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) (2020), cited by 2
- K211334: Iovera System (2021), cited by 2
- K102021: Cryo-Touch II (2010), cited by 2
- K161835: iovera system (2017), cited by 2

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