# K933367: Gore-Tex Facial Implant

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Jul 28, 1994 after 384 days
- Product code: FWP (Prosthesis, Chin, Internal)
- Device class: 2
- Regulation: 21 CFR 878.3550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K091011: Pureform Eptfe Facial Implants (Nasal, Chin, Maler) (2009), 1 descendant of its own
- K201153: Tisuthes e-PTFE Surgical Patch (2023), 0 descendants of its own

Source page: https://510kreport.com/device/K933367
Methodology: https://510kreport.com/methodology