# K170842: Wego-Ptfe

- Pathway: 510(k) (Traditional)
- Applicant: Foosin Medical Supplies Inc., Ltd.
- Decided: Jul 31, 2017 after 132 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 K072076 (2007). 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)
- K072076: Cytoplast Ptfe Suture, Osteogenics Biomedical, Inc. (2007) Summary page 5.

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

## Indications for use
WEGO-PTFE is indicated for use in all types of soft tissue approximation and/or ligation, including cardiovascular, dental and general surgeries. The device is not indicated for use in ophthalmic surgery, microsurgery and peripheral neural tissue.

Source page: https://510kreport.com/device/K170842
Methodology: https://510kreport.com/methodology