# DEN060003: Tephaflex Absorbable Suture

- Pathway: De Novo (Post-NSE)
- Applicant: Tepha, Inc.
- Decided: Feb 8, 2007 after 272 days
- Product code: NWJ (Suture, Recombinant Technology)
- Device class: 2
- Regulation: 21 CFR 878.4494
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
22 later devices descend from it; 4 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K070894: Tephaflex Surgical Mesh (2007), 17 descendants of its own
- K143380: Phasix ST Mesh (2015), 4 descendants of its own
- K142818: Phasix Mesh (2015), 3 descendants of its own
- K140533: Galaflex Mesh (2014), 3 descendants of its own
- K161424: Phasix Mesh (2016), 2 descendants of its own

Source page: https://510kreport.com/device/DEN060003
Methodology: https://510kreport.com/methodology