# K143386: Progrip Laparoscopic Self-Fixating Mesh

- Pathway: 510(k) (Special)
- Applicant: Sofradim Production
- Decided: Mar 13, 2015 after 107 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
Longest line of descent: 7 generations back to K991400 (1999). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Sofradim Production (2014) Summary page 4.

## Indications for use
ProGrip™ laparoscopic self-fixating mesh is indicated for the reinforcement of soft tissues during repair of inguinal hernia defects by laparoscopic approach.

Source page: https://510kreport.com/device/K143386
Methodology: https://510kreport.com/methodology