# K130428: Covamesh

- Pathway: 510(k) (Traditional)
- Applicant: Biomup S.A.
- Decided: Oct 25, 2013 after 247 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: 4 generations back to K850785 (1985). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 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.
- K103081: Covaortho-Nerve Resorbable Collagen Membrane, Biom'Up Sas (2012) Summary page 1.

## Indications for use
Intended for the reinforcement of tissues during surgical repair. It is indicated for the treatment of incisional hernias, abdominal wall repair, and parietal (i.e. pertaining to the walls) reinforcement of tissues. The non-resorbable three dimensional polyester mesh provides long-term reinforcement of soft tissues.

Source page: https://510kreport.com/device/K130428
Methodology: https://510kreport.com/methodology