# K001096: Burr Hole Cover, Model XX

- Pathway: 510(k) (Traditional)
- Applicant: Image-Guided Neurologics, Inc.
- Decided: Oct 25, 2000 after 204 days
- Product code: GXR (Cover, Burr Hole)
- Device class: 2
- Regulation: 21 CFR 882.5250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K123163: Neuropace Burr Hole Cover Model 8110 (2013), 5 descendants of its own
- K141368: Neuropace Burr Hole Cover (2014), 2 descendants of its own
- K160739: Cranial COVER (2016), 1 descendant of its own
- K152342: Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover (2016), 1 descendant of its own
- K192310: Flap Fixator, Burr Hole Cover (2020), 0 descendants of its own

## Recalls of this device
- Jun 2, 2021 · Class II · Z-2228-2021: Excess nylon flash on the clip.

Source page: https://510kreport.com/device/K001096
Methodology: https://510kreport.com/methodology