# K073287: Prevadh Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Sofradim Production
- Decided: Mar 13, 2008 after 113 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: 3 generations back to K991400 (1999). 6 ancestors in all.
17 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040998: Modification to Parietex Composite (Pco) Mesh, Sofradim Production (2004) Summary page 1.
- K810428: Vicryl, ETHICON, Inc. (1981) Summary page 1.
- K033376: Ugytex Mesh, Sofradim Production (2004) Summary page 1.

## 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

## Indications for use
PREVADH mesh is indicated for use when a temporary wound support is required in abdominopelvic surgery. The resorbable hydrophilic film minimizes tissue attachment to the mesh in the case of direct contact with the viscera.

Source page: https://510kreport.com/device/K073287
Methodology: https://510kreport.com/methodology