# K090688: Cook Urological Graft

- Pathway: 510(k) (Traditional)
- Applicant: Cook Biotech, Inc.
- Decided: Jul 10, 2009 after 116 days
- Product code: PAG (Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator)
- 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). 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)
- K980431: Surgisis, Cook Biotech, Inc. (1998) Summary page 1.
- K992159: Surgisis Sling, Cook Biotech, Inc. (1999) Summary page 1.
- K051701: Vicryl * Mesh Bag, ETHICON, Inc. (2005) Summary page 1.

## Indications for use
The COOK Urological Graft is for implantation to reinforce soft tissues where weakness exists in the urological anatomy, including temporary wound or solid organ support in the kidney. The device is supplied sterile and intended for one-time use.

Source page: https://510kreport.com/device/K090688
Methodology: https://510kreport.com/methodology