# GXQ: Dura Substitute

- Device class: 2; regulation: 21 CFR 882.5910; FDA's rule: 510(k) required
- FDA decisions: 43
- 510(k) review time 2021–2025: median 175 days (middle half 124–229)
- 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)
- 2012: 2
- 2013: 3
- 2014: 1
- 2015: 3
- 2016: 3
- 2017: 2
- 2019: 1
- 2022: 1
- 2023: 1
- 2025: 2

## Most-cited predicates
- K982180: Duragen Dural Graft Matrix (1999), cited by 7
- K950956: Dura-Guard Dural Repair Patch, Dura-Guard Dura Substitute (1995), cited by 6
- K032693: Duragen Plus Dural Graft Matrix (2003), cited by 4
- K982282: Dura-Guard - Dural Repair Patch (1998), cited by 4
- K041000: Durepair Dura Regeneration Matrix (2004), cited by 4
- K973706: Dura-Guard-Dural Repair Patch (1997), cited by 4
- K991413: Codman Ethisorb Dura Patch (2000), cited by 3
- K970851: Lyoplant Dura Substitute (Various) (1997), cited by 3
- K043427: Duragen II Dural Regeneration Matrix (2005), cited by 3
- K052211: Durepair Dura Regeneration Matrix (2005), cited by 3

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