# K222919: GORE® ENFORM Biomaterial

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore and Associates, Inc.
- Decided: Dec 19, 2022 after 84 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: 10 generations back to K921895 (1992). 82 ancestors in all.
No later device cites it as a predicate yet.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173333: GORE ENFORM Biomaterial, W. L. Gore & Associates, Inc. (2018) Summary page 4.
- K152609: GORE SYNECOR Biomaterial, W. L. Gore & Associates, Inc. (2015). Our reading of the summary gave K152309, FDA’s number for LOGIQ E9, LOGIQ E9 XDClear 2.0 (GE Medical Systems Ultrasound and Primary Care Diagnostics). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “GORE® SYNECOR Intraperitoneal Biomaterial”.

## 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/K222919
Methodology: https://510kreport.com/methodology