# K161629: Crylrex

- Pathway: 510(k) (Traditional)
- Applicant: Sm Eng Co., Ltd.
- Decided: Feb 10, 2017 after 242 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: 3 generations back to K980704 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130735: Synthetic Absorbable Suture, Foosin Medical Supplies Inc., Ltd. (2014) Summary page 5.

## Indications for use
CRYLREX® 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/K161629
Methodology: https://510kreport.com/methodology