# K062697: Sis Hernia Repair Device, Surgisis Gold Hernia Repair Graft

- Pathway: 510(k) (Special)
- Applicant: Cook Biotech, Inc.
- Decided: Oct 13, 2006 after 32 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
No predicates in its family tree.
31 later devices descend from it; 8 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K094061: Kensey Nash Ecm Surgical Patch (2010), 10 descendants of its own
- K073391: Surgisis Biodesign Tissue Graft (2008), 8 descendants of its own
- K132025: Meso Bilayer Surgical Mesh (2013), 6 descendants of its own
- K163217: GORE BIO-A Tissue Reinforcement (2017), 5 descendants of its own
- K130547: Endoform Reconstructive Template (2013), 5 descendants of its own

## Indications for use
The SIS Hernia Repair Device is intended to be implanted to reinforce soft tissue where weakness exists. Indications for use include the repair of a hernia or body wall defect. The device is intended for one-time use.

Source page: https://510kreport.com/device/K062697
Methodology: https://510kreport.com/methodology