# K142887: SIS Inguinal Hernia Repair Graft

- Pathway: 510(k) (Traditional)
- Applicant: Cook Biotech Incorprated
- Decided: Oct 1, 2015 after 364 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: 10 generations back to K921895 (1992). 43 ancestors in all.
No later device cites it as a predicate yet.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083898: Surgimend, Tei Biosciences, Inc. (2009) Summary page 11.
- K062697: Sis Hernia Repair Device, Surgisis Gold Hernia Repair Graft, Cook Biotech, Inc. (2006) Summary page 11.

## Indications for use
The Inguinal Hernia Repair Graft is intended for implantation to reinforce soft tissues where weakness exists, including the repair of inguinal hernias. The graft is supplied sterile and intended for one time use.

Source page: https://510kreport.com/device/K142887
Methodology: https://510kreport.com/methodology