# K123163: Neuropace Burr Hole Cover Model 8110

- Pathway: 510(k) (Traditional)
- Applicant: NeuroPace, Inc.
- Decided: Jan 18, 2013 after 101 days
- Product code: GXR (Cover, Burr Hole)
- Device class: 2
- Regulation: 21 CFR 882.5250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001096 (2000). 1 ancestor in all.
5 later devices descend from it; 3 cite 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)
- K001096: Burr Hole Cover, Model XX, Image-Guided Neurologics, Inc. (2000) Summary page 1.

## Most influential descendants
- 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
- K181382: GuardianTM Burr Hole Cover System (2018), 0 descendants of its own

## Indications for use
The NeuroPace® Burr Hole Cover is intended for use following cranial surgery to cover a 14 mm burr hole. Secondarily, the NeuroPace Burr Hole Cover also can be used to support a 1.3 mm indwelling lead.

Source page: https://510kreport.com/device/K123163
Methodology: https://510kreport.com/methodology