# K021477: Preclude MVP Dura Substitute

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Nov 8, 2002 after 184 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
Longest line of descent: 3 generations back to K950956 (1995). 8 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984534: Preclude Acuseal Dura Substitute, W. L. Gore & Associates, Inc. (1999) Summary page 1.
- K953969: Preclude Dura Substitute, W. L. Gore & Associates, Inc. (1995) Summary page 1.
- K010936: Modification to Seamguard Staple Line Reinforcement Material, W. L. Gore & Associates, Inc. (2001) Summary page 1.
- K982180: Duragen Dural Graft Matrix, Integra Lifesciences Corp. (1999) Summary page 1.

## Most influential descendants
- 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
The PRECLUDE@MVP Dura Substitute is intended for use as a temporary or permanent prosthesis for repair of dura mater during neurosurgery.

Source page: https://510kreport.com/device/K021477
Methodology: https://510kreport.com/methodology