# K152342: Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: Jun 9, 2016 after 295 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: 3 generations back to K001096 (2000). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123163: Neuropace Burr Hole Cover Model 8110, NeuroPace, Inc. (2013) Summary page 4.
- K141368: Neuropace Burr Hole Cover, NeuroPace, Inc. (2014) Summary page 4.

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

## Indications for use
The Guardian™ Burr Hole Cover System is intended for use during cranial surgery as an implantable 14 mm burr hole cover for the skull. It can also be used to secure a lead with a 1.29 mm (0.051 in) or 1.39 mm (0.055 in) diameter.

Source page: https://510kreport.com/device/K152342
Methodology: https://510kreport.com/methodology