# K162934: Biodesign Parastomal Hernia Repair Graft

- Pathway: 510(k) (Traditional)
- Applicant: Cook Biotech Incorporated
- Decided: Jul 10, 2017 after 263 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: 4 generations back to K921895 (1992). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043366: Permacol Surgical Implant, Tissue Science Laboratories, Plc (2004) Summary page 4.

## Most influential descendants
- K261543: Phasix ST Parastomal Hernia Mesh (2026), 0 descendants of its own

## Indications for use
The Biodesign Parastomal Hernia Repair Graft is intended for use as a soft tissue patch where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for the repair of abdominal wall defects and hernias, including but not limited to parastomal hernias.

Source page: https://510kreport.com/device/K162934
Methodology: https://510kreport.com/methodology