# K133011: Diaphragmatic Hernia Graft

- Pathway: 510(k) (Traditional)
- Applicant: Cook Biotech, Inc.
- Decided: Jun 20, 2014 after 268 days
- Product code: OWV (Mesh, Surgical, Collagen, Diaphragmatic Hernia)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K881854 (1988). 35 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 37 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.
- K022044: Surgisis Staple Line Reinforcement, Cook Biotech, Inc. (2002) Summary page 1.
- K120605: Permacol Surgical Implant, Covidien, LLC (2012) Summary page 1.

## Most influential descendants
- K171817: Biodesign Diaphragmatic Hernia Graft (2018), 0 descendants of its own

## Recalls of this device
- Nov 22, 2024 · Class II · Z-0833-2025: Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.

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

Source page: https://510kreport.com/device/K133011
Methodology: https://510kreport.com/methodology