# K130006: Biodesign Surgisis Anterior Posterior Pelvic Floor Grafts

- Pathway: 510(k) (Traditional)
- Applicant: Cook Biotech Incorporated
- Decided: Apr 5, 2013 after 93 days
- Product code: PAI (Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed)
- Device class: 3
- Regulation: 21 CFR 884.5980
- 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). 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)
- K992159: Surgisis Sling, Cook Biotech, Inc. (1999) Summary page 4.
- K062696: Surgisis, Surgisis ES, Cook Biotech, Inc. (2006) Summary page 4.

## Indications for use
Cook® Biodesign® Surgisis® Anterior Pelvic Floor Graft is indicated for tissue reinforcement in women with pelvic organ prolapse, for transvaginal repair of anterior and anterior/apical vaginal vault prolapse. Cook® Biodesign® Surgisis® Posterior Pelvic Floor Graft is indicated for tissue reinforcement in women with pelvic organ prolapse, for transvaginal repair of posterior and posterior/apical vaginal vault prolapse.

Source page: https://510kreport.com/device/K130006
Methodology: https://510kreport.com/methodology