# K173747: Rexlene

- Pathway: 510(k) (Traditional)
- Applicant: Sm Eng Co., Ltd.
- Decided: Dec 21, 2018 after 378 days
- Product code: GAW (Suture, Nonabsorbable, Synthetic, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 878.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K930586 (1993). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080684: WG-Surgical Sutures with Needle, Foosin Medical Supplies, Inc. (2008) Summary page 5.

## Most influential descendants
- K222944: SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture (2024), 0 descendants of its own

## Indications for use
REXLENE is indicated for use in general soft tissue approximation and/or ligation. including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.

Source page: https://510kreport.com/device/K173747
Methodology: https://510kreport.com/methodology