# K960656: Gore Burr Hole Cover

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Aug 14, 1996 after 181 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 K820311 (1982). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K820311: H-H Burr Hole Catheter Support, Holter-Hausner Intl. (1982) Summary page 1.
- K913490: Phoenix Burr Hole Button, Burr 1, Phoenix Bioengineering, Inc. (1992) Summary page 1.
- K922489: Medpor Surg Implant Material:Prefor Cran/Fac Impla, Porex Technologies Corp. (1992) Summary page 1.

## Indications for use
Like the predicate devices, the GORE Burr Hole Cover is intended to be used as a burr hole cover following cranial surgery.

Source page: https://510kreport.com/device/K960656
Methodology: https://510kreport.com/methodology