# K043191: Repol Angimesh, Angimesh Pre, Folded Mesh, Repol Plug Basic, Repol Plug Cap, Repol Plug Flower and Wings Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Angiologica B. M. Srl
- Decided: May 16, 2005 after 180 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bard Mesh: named in the summary without a submission number

## Indications for use
Ancilmesh Pre: "Repair of inguinal hernia defects." Folded Mesh: "Repair of inguinal hernia defects." Repol Plug Basic: "Repair of inguinal hernia defects." Repol Plug Cap: "Repair of inguinal hernia defects." Repol Plug Flower: "Repair of inguinal hernia defects." Repol Angimesh: "To reinforce soft tissue where weakness exists, i.e., repair of hernias." Winqs Mesh: "Use in all kind of hernia repair requiring reinforcement with non-absorbable support material."

Source page: https://510kreport.com/device/K043191
Methodology: https://510kreport.com/methodology