# K003990: Sofradim Parietex Surgical Meshes

- Pathway: 510(k) (Special)
- Applicant: Sofradim Production
- Decided: Jan 24, 2001 after 29 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
16 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K081050: Parietex Progrip Mesh (2008), 15 descendants of its own
- K103682: Parietex Progrip (2011), 6 descendants of its own
- K101519: Parietex Plug and Patch (2010), 6 descendants of its own
- K101197: Parie Tene Progrip Mesh (2010), 6 descendants of its own
- K142900: Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh (2014), 5 descendants of its own

Source page: https://510kreport.com/device/K003990
Methodology: https://510kreport.com/methodology