# K153364: Kerecis SecureMesh

- Pathway: 510(k) (Traditional)
- Applicant: Kerecis Limited
- Decided: Aug 19, 2016 after 273 days
- Product code: OXE (Mesh, Surgical, Collagen, Staple Line Reinforcement)
- 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: 8 generations back to K921895 (1992). 70 ancestors in all.
No later device cites it as a predicate yet.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041669: Veritas Dry Collagen Matrix, Veritas Dry or Veritas PSD, Synovis Surgical Innovations (2004) Summary page 4.
- K132343: Marigen Wound Dressing, Kerecis Limited (2013) Summary page 4.

## Indications for use
Kerecis SecureMesh is intended for use as a prosthesis when staple line reinforcement is needed in surgical repair of soft tissue deficiencies using surgical staplers. Kerecis SecureMesh can be used for reinforcement of staple lines during: - Bariatric surgical procedures - Colorectal and Colon surgical procedures - Gastric, small bowels and mesentery procedures - Lung and bronchus resections

Source page: https://510kreport.com/device/K153364
Methodology: https://510kreport.com/methodology