# K082682: Surgisis Biodesign Enterocutaneous Fistula Plug

- Pathway: 510(k) (Traditional)
- Applicant: Cook Biotech, Inc.
- Decided: Feb 27, 2009 after 165 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: 5 generations back to K921895 (1992). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050337: Sis Fistula Plug, Cook Biotech, Inc. (2005) Summary page 1.

## Most influential descendants
- K150668: Biodesign Enterocutaneous Fistula Plug (2015), 0 descendants of its own

## Indications for use
The modified SIS Fistula Plug is indicated for implantation to reinforce soft tissue for repair of enterocutaneous fistulas.

Source page: https://510kreport.com/device/K082682
Methodology: https://510kreport.com/methodology