# K191696: Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft

- Pathway: 510(k) (Traditional)
- Applicant: Cook Biotech Incorporated
- Decided: Dec 27, 2019 after 185 days
- Product code: OXN (Mesh, Surgical, Collagen, Fistula)
- 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). 28 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161221: Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug, Cook Biotech Incorporated (2016) Summary page 7.
- K050337: Sis Fistula Plug, Cook Biotech, Inc. (2005) Summary page 7.
- K170016: Biodesign Fistula Plug, Cook Biotech Incorporated (2017) Summary page 7.
- K034039: Sis Plastic Surgery Matrix, Cook Biotech, Inc. (2004) Summary page 7.
- K160896: Ultrashape Power System, Syneron Medical, Ltd. (2016) Summary page 7.
- K980431: Surgisis, Cook Biotech, Inc. (1998) Summary page 7.

## Most influential descendants
- K202430: Kerecis Reconstruct (2021), 3 descendants of its own
- K251844: Kerecis SurgiBind (50241) (2025), 0 descendants of its own
- K251224: Restrata Soft Tissue Reinforcement (STR) (2025), 0 descendants of its own
- K243843: Tendon Protect (50242) (2025), 0 descendants of its own

## Indications for use
For implantation to reinforce soft tissue where a rolled configuration is required, for repair of anal, rectal and enterocutaneous fistulas. For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. For implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery. For implantation to reinforce soft tissue.

Source page: https://510kreport.com/device/K191696
Methodology: https://510kreport.com/methodology