# K062729: Surgisis RVP Recto-Vaginal Fistula Plug

- Pathway: 510(k) (Special)
- Applicant: Cook Biotech, Inc.
- Decided: Oct 10, 2006 after 27 days
- Product code: FTM (Mesh, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 12 (0 Class I)
- 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.
No later device cites it as a predicate yet.
0 of 12 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.

## Recalls of this device
- Aug 7, 2024 · Class II · Z-3260-2024: Products expire prior to the expiration date printed on the product labeling
- Aug 7, 2024 · Class II · Z-3261-2024: Products expire prior to the expiration date printed on the product labeling
- Aug 7, 2024 · Class II · Z-3254-2024: Products expire prior to the expiration date printed on the product labeling
- Aug 7, 2024 · Class II · Z-3252-2024: Products expire prior to the expiration date printed on the product labeling
- Aug 7, 2024 · Class II · Z-3251-2024: Products expire prior to the expiration date printed on the product labeling
- Aug 7, 2024 · Class II · Z-3256-2024: Products expire prior to the expiration date printed on the product labeling
- Aug 7, 2024 · Class II · Z-3255-2024: Products expire prior to the expiration date printed on the product labeling
- Aug 7, 2024 · Class II · Z-3259-2024: Products expire prior to the expiration date printed on the product labeling
- Aug 7, 2024 · Class II · Z-3257-2024: Products expire prior to the expiration date printed on the product labeling
- Aug 7, 2024 · Class II · Z-3258-2024: Products expire prior to the expiration date printed on the product labeling
- Aug 7, 2024 · Class II · Z-3253-2024: Products expire prior to the expiration date printed on the product labeling
- Aug 7, 2024 · Class II · Z-3250-2024: Products expire prior to the expiration date printed on the product labeling

## Indications for use
The modified SIS Fistula Plug is for implantation to reinforce soft tissue for repair of recto-vaginal fistulas. The device is supplied sterile and is intended for one-time use.

Source page: https://510kreport.com/device/K062729
Methodology: https://510kreport.com/methodology