# K163639: LS-5 ePTFE Suture

- Pathway: 510(k) (Traditional)
- Applicant: Lsi Solutions
- Decided: Jun 2, 2017 after 161 days
- Product code: NBY (Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene)
- Device class: 2
- Regulation: 21 CFR 878.5035
- 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)
- P820083: Gore-Tex (R) Expanded Ptfe Suture, W. L. Gore & Associates, Inc.. FDA lists this PMA only through its supplements; the earliest we hold is P820083/S001 (May 12, 1986). Summary page 5.

## Indications for use
The LS-5™ ePTFE Suture is indicated for use in all types of soft tissue approximation, including use in cardiovascular surgery.

Source page: https://510kreport.com/device/K163639
Methodology: https://510kreport.com/methodology