# K161633: Rexlon, Rexsil

- Pathway: 510(k) (Traditional)
- Applicant: Sm Eng Co., Ltd.
- Decided: Mar 2, 2017 after 262 days
- Product code: GAR (Suture, Nonabsorbable, Synthetic, Polyamide)
- Device class: 2
- Regulation: 21 CFR 878.5020
- 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). 17 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 22 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 8.
- K982646: Ailee Sutures and Ailee Needles, Myco Medical Supplies, Inc. (1999) Summary page 8.

## Most influential descendants
- K180701: SafePath Suturing System (2018), 1 descendant of its own
- K222944: SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture (2024), 0 descendants of its own
- K232355: Non absorbable Surgical Silk Suture (2024), 0 descendants of its own
- K212888: Golnit Nylon Monofilament Suture (2022), 0 descendants of its own

## Indications for use
REXLON 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. REXSIL 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/K161633
Methodology: https://510kreport.com/methodology