510(k) · Cleared
ClearedGore Burr Hole Cover
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W. L. Gore & Associates, Inc. · GXR Cover, Burr Hole
Cleared on Aug 14, 1996 as substantially equivalent to K820311 (Holter-Hausner Intl., 1982) and 2 other predicates after a 181-day review. Its family tree reaches back 1 generation to 1982.
- Decided
- Aug 14, 1996
- Review
- 181 days
- Class
- Class II
- Product code
- GXR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K820311 (1982). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK820311 H-H Burr Hole Catheter SupportHolter-Hausner Intl. · 1982
- This deviceK960656 Gore Burr Hole CoverW. L. Gore & Associates, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K820311 | H-H Burr Hole Catheter Support | Holter-Hausner Intl. | 1982 | — |
| 0 (this device) | K960656 | Gore Burr Hole Cover | W. L. Gore & Associates, Inc. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GXR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GXR device
- #1 K253447 Montage Flowable Settable, Resorbable Bone…score 13.7 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K820311 | H-H Burr Hole Catheter SupportSummary page 1…icate Device: For the purposes of determining substantial equivalence, GORE cites the following as predicate devices: ¢ Holter - Hausner - Burr Hole Catheter Support - K 820311 e Phoenix Bioengineering - Phoenix Burr Hole Button - K 913490 e Porex Surgical Inc. - Medpor FLEXBLOCK Implant - K 922489 Appli… | 1982 |
| * | K913490 | Phoenix Burr Hole Button, Burr 1Summary page 1…valence, GORE cites the following as predicate devices: ¢ Holter - Hausner - Burr Hole Catheter Support - K 820311 e Phoenix Bioengineering - Phoenix Burr Hole Button - K 913490 e Porex Surgical Inc. - Medpor FLEXBLOCK Implant - K 922489 Applicant Device Description: The GORE Burr Hole Cover device is co… | 1992 |
| * | K922489 | Medpor Surg Implant Material:Prefor Cran/Fac ImplaSummary page 1…olter - Hausner - Burr Hole Catheter Support - K 820311 e Phoenix Bioengineering - Phoenix Burr Hole Button - K 913490 e Porex Surgical Inc. - Medpor FLEXBLOCK Implant - K 922489 Applicant Device Description: The GORE Burr Hole Cover device is composed of expanded polytetrafluoroethylene (ePTFE) and fluor… | 1992 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All GXR devicesGXR Cover, Burr Hole: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GXR
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GXR
116in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXR
No recall names GXR since 2007.
Adverse event reports per year · GXR
10in 2025
MAUDE reports naming product code GXR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 3 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 4 | 116 | 0 | 4 |
| 2014 | 2 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 2 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 2 | — | 0 | 45 |
| 2019 | 0 | — | 0 | 28 |
| 2020 | 2 | — | 0 | 16 |
| 2021 | 0 | — | 0 | 28 |
| 2022 | 0 | — | 0 | 13 |
| 2023 | 1 | — | 0 | 11 |
| 2024 | 1 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Like the predicate devices, the GORE Burr Hole Cover is intended to be used as a burr hole cover following cranial surgery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K960656 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960656: Gore Burr Hole Cover.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960656
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026