# K050337: Sis Fistula Plug

- Pathway: 510(k) (Traditional)
- Applicant: Cook Biotech, Inc.
- Decided: Mar 9, 2005 after 27 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). 10 ancestors in all.
27 later devices descend from it; 8 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980431: Surgisis, Cook Biotech, Inc. (1998)
- K992159: Surgisis Sling, Cook Biotech, Inc. (1999) Summary page 1.

## Most influential descendants
- K083266: Gore Bio-a Fistula Plug (2009), 12 descendants of its own
- K132397: Gore Bio-a Wound Matrix (2014), 10 descendants of its own
- K161221: Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug (2016), 6 descendants of its own
- K170016: Biodesign Fistula Plug (2017), 5 descendants of its own
- K191696: Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft (2019), 4 descendants of its own

## Indications for use
The SIS Fistula Plug is for implantation to reinforce soft tissue where a rolled configuration is required, for repair of anal, rectal, and enterocutaneous fistulas. The device is supplied sterile and is intended for one-time use.

Source page: https://510kreport.com/device/K050337
Methodology: https://510kreport.com/methodology