# K180992: Biotex

- Pathway: 510(k) (Abbreviated)
- Applicant: Purgo Biologics, Inc.
- Decided: Jul 16, 2019 after 456 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.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
Biotex Non-Absorbable PTFE Suture is indicated for use in dental soft tissue approximation and/or ligation. The device is not indicated for use in cardiovascular, ophthalmic surgery, microsurgery or peripheral neural tissue. Biotex is provided sterile as a single use device and the duration of use or contact with the body is less than 30 days.

Source page: https://510kreport.com/device/K180992
Methodology: https://510kreport.com/methodology