510(k) · Cleared
ClearedDura-Guard-Dural Repair Patch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Vascular, Inc. · GXQ Dura Substitute
Cleared on Dec 24, 1997 as substantially equivalent to K950956 (Bio-Vascular, Inc., 1995) after an 86-day review. Its family tree reaches back 1 generation to 1995. 33 later devices descend from it.
- Decided
- Dec 24, 1997
- Review
- 86 days
- Class
- Class II
- Product code
- GXQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K950956 (1995). 33 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK950956 Dura-Guard Dural Repair Patch, Dura-Guard Dura SubstituteBio-Vascular, Inc. · 1995
- This deviceK973706 Dura-Guard-Dural Repair PatchBio-Vascular, Inc. · 1997
- Descendant · cites it directly · 30 of its ownK982180 Duragen Dural Graft MatrixIntegra Lifesciences Corp. · 1999 · Recalled
- Descendant · cites it directly · 13 of its ownK982282 Dura-Guard - Dural Repair PatchBio-Vascular, Inc. · 1998 · Recalled
- Descendant · 2 generations on · 9 of its ownK032693 Duragen Plus Dural Graft MatrixIntegra Lifesciences Corp. · 2003 · Recalled
- Descendant · 2 generations on · 7 of its ownK041000 Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2004
- Descendant · 3 generations on · 5 of its ownK052211 Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2005
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K982180Duragen Dural Graft MatrixIntegra Lifesciences Corp. · 1999 · cites it directly30descendants
- K982282Dura-Guard - Dural Repair PatchBio-Vascular, Inc. · 1998 · cites it directly13descendants
- K032693Duragen Plus Dural Graft MatrixIntegra Lifesciences Corp. · 2003 · 2 generations on9descendants
- K041000Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2004 · 2 generations on7descendants
- K052211Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2005 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950956 | Dura-Guard Dural Repair Patch, Dura-Guard Dura Substitute | Bio-Vascular, Inc. | 1995 | — |
| 0 (this device) | K973706 | Dura-Guard-Dural Repair Patch | Bio-Vascular, Inc. | 1997 | — |
| +1 | K982180 | Duragen Dural Graft Matrix | Integra Lifesciences Corp. | 1999 | 1 |
| +1 | K982282 | Dura-Guard - Dural Repair Patch | Bio-Vascular, Inc. | 1998 | 1 |
| +2 | K032693 | Duragen Plus Dural Graft Matrix | Integra Lifesciences Corp. | 2003 | 1 |
| +2 | K041000 | Durepair Dura Regeneration Matrix | Medtronic Neurosurgery | 2004 | — |
| +3 | K052211 | Durepair Dura Regeneration Matrix | Medtronic Neurosurgery | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 GXQ? 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 GXQ device
- #1 K251191 Collagen Dura Regeneration Membrane - Repairscore 12.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K950956 | Dura-Guard Dural Repair Patch, Dura-Guard Dura SubstituteSummary page 1…Affairs Manager Date Prepared: September 26, 1997 Common or Usual Name: Dura-Guard® Device Classification Name: Dural Repair Patch Substantial Equivilance: Dura-Guard K950956 Device Description: Dura-Guard is a dural repair patch manufactured from bovine pericardium cross-linked with glutaraldehyde. S… | 1995 |
What descends from it? (33)
See all 334 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All GXQ devicesGXQ Dura Substitute: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GXQ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXQ
94in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXQ
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXQ
61in 2025
MAUDE reports naming product code GXQ, 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 | 2 | — | 0 | 55 |
| 2008 | 0 | — | 0 | 43 |
| 2009 | 0 | — | 0 | 46 |
| 2010 | 1 | — | 6 | 36 |
| 2011 | 0 | — | 0 | 31 |
| 2012 | 2 | — | 0 | 38 |
| 2013 | 3 | 181 | 1 | 72 |
| 2014 | 1 | — | 0 | 18 |
| 2015 | 3 | 214 | 0 | 62 |
| 2016 | 3 | 94 | 0 | 58 |
| 2017 | 2 | — | 0 | 57 |
| 2018 | 0 | — | 0 | 94 |
| 2019 | 1 | — | 0 | 63 |
| 2020 | 0 | — | 0 | 114 |
| 2021 | 0 | — | 2 | 76 |
| 2022 | 1 | — | 0 | 59 |
| 2023 | 1 | — | 0 | 109 |
| 2024 | 0 | — | 2 | 55 |
| 2025 | 2 | — | 0 | 61 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For use as a dural substitute for the closure of dura mater during neurosurgery.
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/K973706 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973706: Dura-Guard-Dural Repair Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973706
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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