# K160744: LOOK PTFE Suture

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Specialties Corporation
- Decided: Jul 13, 2016 after 118 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: 2 generations back to K072076 (2007). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 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 4.
- K140415: Monotex, Riverpoint Medical (2014) Summary page 4.

## Most influential descendants
- K233355: Cypris eXact Suturing System (2024), 0 descendants of its own
- K181578: DemeTECH PTFE Nonabsorbable Surgical Suture (2018), 0 descendants of its own

## Indications for use
PTFE (polytetrafluoroethylene) suture is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgeries

Source page: https://510kreport.com/device/K160744
Methodology: https://510kreport.com/methodology