# K071629: Parietex Polyester Mesh with Introducer

- Pathway: 510(k) (Special)
- Applicant: Sofradim Production
- Decided: Jul 10, 2007 after 26 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: 1 generation back to K982532 (1999). 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)
- K982532: Parietex, Cogent (1999) Summary page 1.

## Indications for use
The Parietex® Polyester Mesh is indicated for use in the reinforcement of tissue during surgical repair of inguinal hernias through laparoscopic approach.

Source page: https://510kreport.com/device/K071629
Methodology: https://510kreport.com/methodology