# GXR: Cover, Burr Hole

- Device class: 2; regulation: 21 CFR 882.5250; FDA's rule: 510(k) required
- FDA decisions: 29
- 510(k) review time 2021–2025: median 283 days (middle half 156–410)
- 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)
- 2007: 1
- 2010: 2
- 2013: 4
- 2014: 2
- 2016: 2
- 2018: 2
- 2020: 2
- 2023: 1
- 2024: 1
- 2026: 1

## Most-cited predicates
- K132044: Cranial Loop, Cranial Loop L and Cranial Loop XL and Cranial Bone Fixation System (2013), cited by 3
- K040080: Aesculap Absorbable Craniofix (2004), cited by 3
- K041611: Synthes (Usa) Rapid Resorbable Cranial Clamp (2004), cited by 3
- K123163: Neuropace Burr Hole Cover Model 8110 (2013), cited by 3
- K002334: Macroporens Craniloc (2001), cited by 2
- K021408: Resorbable Cranial Clamps (2002), cited by 2
- K010361: Medtronic PS Medical Invisx Cranial Fixation System, Model 60100-60900 (2001), cited by 2
- K152342: Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover (2016), cited by 1
- K913490: Phoenix Burr Hole Button, Burr 1 (1992), cited by 1
- K001096: Burr Hole Cover, Model XX (2000), cited by 1

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