# K173333: GORE ENFORM Biomaterial

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Apr 5, 2018 after 164 days
- Product code: OXF (Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K921895 (1992). 81 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163217: GORE BIO-A Tissue Reinforcement, W. L. Gore & Associates, Inc. (2017) Summary page 4.
- K152609: GORE SYNECOR Biomaterial, W. L. Gore & Associates, Inc. (2015) Summary page 4.
- K143380: Phasix ST Mesh, C.R. Bard, Inc. (2015) Summary page 4.

## Most influential descendants
- K222919: GORE® ENFORM Biomaterial (2022), 0 descendants of its own

## Indications for use
GORE® ENFORM Biomaterial is indicated for use in the reinforcement of soft tissue. This includes use in patients requiring soft tissue reinforcement in plastic and reconstructive surgery. Examples of applications where GORE® ENFORM Biomaterial may be used include hernia repair as suture line reinforcement, muscle flap reinforcement, and general tissue reconstructions.

Source page: https://510kreport.com/device/K173333
Methodology: https://510kreport.com/methodology