# K212888: Golnit Nylon Monofilament Suture

- Pathway: 510(k) (Abbreviated)
- Applicant: Antarma, LLC Dba Golnit Sutures
- Decided: Mar 31, 2022 after 202 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: 5 generations back to K930586 (1993). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161633: Rexlon, Rexsil, Sm Eng Co., Ltd. (2017) Summary page 4.

## Indications for use
The Golnit Nylon Monofilament Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neurological procedures.

Source page: https://510kreport.com/device/K212888
Methodology: https://510kreport.com/methodology