# K162388: CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas (PICS-AF)

- Pathway: 510(k) (Traditional)
- Applicant: Curaseal, Inc.
- Decided: Feb 3, 2017 after 162 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: 8 generations back to K842066 (1985). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083266: Gore Bio-a Fistula Plug, W. L. Gore & Associates, Inc. (2009) Summary page 5.
- K050337: Sis Fistula Plug, Cook Biotech, Inc. (2005) Summary page 5.

## Indications for use
The CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas (PICS-AF™) is for implantation to reinforce soft tissue for the repair of anal and rectal fistulas.

Source page: https://510kreport.com/device/K162388
Methodology: https://510kreport.com/methodology