# K192088: GOLNIT Non-aborbable PTFE Surgical Suture

- Pathway: 510(k) (Special)
- Applicant: Antarma, LLC Dba Golnit Sutures
- Decided: Sep 4, 2019 after 30 days
- Product code: NBY (Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene)
- Device class: 2
- Regulation: 21 CFR 878.5035
- 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 K072076 (2007). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163049: GOLNIT Non-Absorbable PTFE Surgical Suture, Antarma Dba Golnit Sutures (2017) Summary page 4.
- K072076: Cytoplast Ptfe Suture, Osteogenics Biomedical, Inc. (2007) Summary page 4.
- K170842: Wego-Ptfe, Foosin Medical Supplies Inc., Ltd. (2017) Summary page 4.
- K173335: Gazelle PTFE and Suture Delivery Device, Dura Tap, LLC (2018) Summary page 4.

## Indications for use
The GOLNIT Non-Absorbable PTFE Surgical Suture is indicated for use in all types of soft tissue approximation and/or ligation, including dental, cardiovascular and general surgeries, as well as repair of the dura mater. The device is not indicated for use in ophthalmic surgery, microsurgery and peripheral neural tissue.

Source page: https://510kreport.com/device/K192088
Methodology: https://510kreport.com/methodology