# K160739: Cranial COVER

- Pathway: 510(k) (Traditional)
- Applicant: Neos Surgery S.L
- Decided: Jun 12, 2016 after 87 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: 4 generations back to K002334 (2001). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983885: Burr Hole Covers, Craniomaxillofacial Plates, Howmedica, Inc. (1999) Summary page 4.
- K123163: Neuropace Burr Hole Cover Model 8110, NeuroPace, Inc. (2013) Summary page 4.
- K132044: Cranial Loop, Cranial Loop L and Cranial Loop XL and Cranial Bone Fixation System, Neos Surgery S.L (2013) Summary page 4.

## Most influential descendants
- K192310: Flap Fixator, Burr Hole Cover (2020), 0 descendants of its own

## Indications for use
The Cranial COVER is intended for use to cover burr holes resulting from cranial surgery. With the available sizes, burr holes with an epicranial diameter between 10 and 14 mm, made with standard perforators or with spherical drills, can be covered.

Source page: https://510kreport.com/device/K160739
Methodology: https://510kreport.com/methodology