# K150668: Biodesign Enterocutaneous Fistula Plug

- Pathway: 510(k) (Traditional)
- Applicant: Cook Biotech Incorprated
- Decided: Dec 9, 2015 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: 6 generations back to K921895 (1992). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082682: Surgisis Biodesign Enterocutaneous Fistula Plug, Cook Biotech, Inc. (2009) Summary page 4.

## Indications for use
The Biodesign® Enterocutaneous Fistula Plug is intended for implantation to reinforce soft tissue for repair of enterocutaneous fistulas. The device is supplied sterile and is intended for one-time use.

Source page: https://510kreport.com/device/K150668
Methodology: https://510kreport.com/methodology