# K061727: Gore Preclude Vessel Guard

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Aug 7, 2006 after 49 days
- Product code: MFX (Vessel Guard Or Cover, To Facilitate Revision Surgeries)
- Device class: 2
- Regulation: 21 CFR 870.3470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K811841 (1981). 4 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984526: Acuseal Cardiovascular Patch, W. L. Gore & Associates, Inc. (1999) Summary page 2.

## Most influential descendants
- K082782: Replication Medical Vessel Guard (2009), 3 descendants of its own
- K103558: Synthes Scout Vessel Guard (2011), 1 descendant of its own
- K111048: Synthes Scout Tack Fixation (2012), 0 descendants of its own
- K101805: Hydrofix Vaso Shield (2011), 0 descendants of its own
- K100984: Xylos Vessel Guard (2010), 0 descendants of its own

## Indications for use
The Gore PRECLUDE® Vessel Guard is indicated as a cover for vessels following anterior vertebral surgery to reduce the risk of potential vessel damage during a revision surgery by providing a plane of dissection.

Source page: https://510kreport.com/device/K061727
Methodology: https://510kreport.com/methodology