510(k) · Cleared
ClearedPreclude Acuseal Dura Substitute
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W. L. Gore & Associates, Inc. · GXQ Dura Substitute
Cleared on Mar 15, 1999 after an 84-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Mar 15, 1999
- Review
- 84 days
- Class
- Class II
- Product code
- GXQ
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK984534 Preclude Acuseal Dura SubstituteW. L. Gore & Associates, Inc. · 1999
- Descendant · cites it directly · 3 of its ownK021477 Preclude MVP Dura SubstituteW. L. Gore & Associates, Inc. · 2002
- Descendant · 2 generations on · 2 of its ownK113071 Synthecel Dura Replacement DevicesSynthes · 2012 · Recalled
- Descendant · 3 generations on · 1 of its ownK131792 Synthecel Dura Repair, Synthecel Dura OnlaySynthes, Inc. · 2013 · Recalled
- Descendant · 3 generations on · 0 of its ownK212943 SyntheCel Dura RepairSynthes (USA) Products, LLC · 2022
Most influential descendants
Showing 4 of 4 · See all- K021477Preclude MVP Dura SubstituteW. L. Gore & Associates, Inc. · 2002 · cites it directly3descendants
- K113071Synthecel Dura Replacement DevicesSynthes · 2012 · 2 generations on2descendants
- K131792Synthecel Dura Repair, Synthecel Dura OnlaySynthes, Inc. · 2013 · 3 generations on1descendant
- K212943SyntheCel Dura RepairSynthes (USA) Products, LLC · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K984534 | Preclude Acuseal Dura Substitute | W. L. Gore & Associates, Inc. | 1999 | — |
| +1 | K021477 | Preclude MVP Dura Substitute | W. L. Gore & Associates, Inc. | 2002 | — |
| +2 | K113071 | Synthecel Dura Replacement Devices | Synthes | 2012 | 5 |
| +3 | K131792 | Synthecel Dura Repair, Synthecel Dura Onlay | Synthes, Inc. | 2013 | 5 |
| +3 | K212943 | SyntheCel Dura Repair | Synthes (USA) Products, LLC | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2022 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | — | PRECLUDE® Dura Substitute Named without a submission number | |
| * | — | Silastic® Reinforced Sheeting Named without a submission number | |
| * | — | DuraGuard® Named without a submission number | |
| * | — | Neuro-Patch Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021477 | Preclude MVP Dura Substitute | 2002 | 3 |
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?
- Of its descendants, K021477 (W. L. Gore & Associates, Inc., 2002) has gone furthest, with 3 descendants of its own.
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 temporary or permanent prosthesis for repair 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/K984534 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984534: Preclude Acuseal Dura Substitute.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984534
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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