# K133306: Sis Hernia Graft

- Pathway: 510(k) (Traditional)
- Applicant: Cook Biotech, Inc.
- Decided: Jul 23, 2014 after 268 days
- Product code: FTM (Mesh, Surgical)
- 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: 1 generation back to K974540 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974540: Sis Hernia Repair Device, Sentron Medical, Inc. (1998) Summary page 1.
- K062697: Sis Hernia Repair Device, Surgisis Gold Hernia Repair Graft, Cook Biotech, Inc. (2006) Summary page 1.

## Indications for use
The SIS Hernia Graft is intended for implantation to reinforce soft tissues where weakness exists. Indications for use include repair of a hernia or body wall defect. The graft is supplied sterile and intended for one time only use.

Source page: https://510kreport.com/device/K133306
Methodology: https://510kreport.com/methodology