# K200392: Rexsin

- Pathway: 510(k) (Traditional)
- Applicant: Sm Eng Co., Ltd.
- Decided: Jul 7, 2020 after 140 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K014153 (2002). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073614: WG-Surgical Sutures with Needle, Foosin Medical Supplies, Inc. (2008) Summary page 4.

## Indications for use
REXSIN 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/K200392
Methodology: https://510kreport.com/methodology