# K181578: DemeTECH PTFE Nonabsorbable Surgical Suture

- Pathway: 510(k) (Traditional)
- Applicant: Demetech Corporation
- Decided: Oct 11, 2018 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: 3 generations back to K072076 (2007). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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.
- K160744: LOOK PTFE Suture, Surgical Specialties Corporation (2016) Summary page 4.

## Indications for use
The DemeTECH PTFE Suture is indicated for use in all types of soft tissue approximation and/or ligation, including 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/K181578
Methodology: https://510kreport.com/methodology