# K964761: S.a.M. Facial Implant W/Introducer

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Jan 27, 1997 after 61 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) S.A.M. Facial Implant: named in the summary without a submission number

## Indications for use
The S.A.M. Facial Implant devices are intended to be used for facial plastic and reconstructive surgery.

Source page: https://510kreport.com/device/K964761
Methodology: https://510kreport.com/methodology