# K070918: 4DDOME

- Pathway: 510(k) (Traditional)
- Applicant: Cousin Biotech
- Decided: Aug 22, 2007 after 142 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 K842066 (1985). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033671: Gore Bioabsorbable Mesh, W. L. Gore & Associates, Inc. (2003) Summary page 1.
- K922916: Bard Marlex Mesh Dart, C.R. Bard, Inc. (1992) Summary page 1.
- K930669: Atrium Polypropylene Mesh, Atrium Medical Corp. (1993) Summary page 1.

## Indications for use
4DDome® is a semi-resorbable surgical plug and mesh for abdominal reinforcement, including open surgical repair and reinforcement of iguinal and crural hernias.

Source page: https://510kreport.com/device/K070918
Methodology: https://510kreport.com/methodology