# K163049: GOLNIT Non-Absorbable PTFE Surgical Suture

- Pathway: 510(k) (Traditional)
- Applicant: Antarma Dba Golnit Sutures
- Decided: Jun 21, 2017 after 232 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: 1 generation back to K003028 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003028: Cytoplast Suture; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC, Osteogenics Biomedical, Inc. (2000) Summary page 4.

## Most influential descendants
- K192088: GOLNIT Non-aborbable PTFE Surgical Suture (2019), 0 descendants of its own

## Indications for use
GOLNIT Non-Absorbable PTFE Surgical Suture is a removable, non-absorbable surgical suture intended for use in the approximation and ligation of soft tissue in the oral cavity including fixation of barrier membranes.

Source page: https://510kreport.com/device/K163049
Methodology: https://510kreport.com/methodology