# K984534: Preclude Acuseal Dura Substitute

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Mar 15, 1999 after 84 days
- Product code: GXQ (Dura Substitute)
- Device class: 2
- Regulation: 21 CFR 882.5910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) PRECLUDE® Dura Substitute: named in the summary without a submission number
- (no number) Silastic® Reinforced Sheeting: named in the summary without a submission number
- (no number) DuraGuard®: named in the summary without a submission number
- (no number) Neuro-Patch: named in the summary without a submission number

## Most influential descendants
- K021477: Preclude MVP Dura Substitute (2002), 3 descendants of its own
- K113071: Synthecel Dura Replacement Devices (2012), 2 descendants of its own
- K131792: Synthecel Dura Repair, Synthecel Dura Onlay (2013), 1 descendant of its own
- K212943: SyntheCel Dura Repair (2022), 0 descendants of its own

## Indications for use
For use as a temporary or permanent prosthesis for repair of dura mater during neurosurgery.

Source page: https://510kreport.com/device/K984534
Methodology: https://510kreport.com/methodology