# K992159: Surgisis Sling

- Pathway: 510(k) (Traditional)
- Applicant: Cook Biotech, Inc.
- Decided: Sep 23, 1999 after 90 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: 3 generations back to K921895 (1992). 9 ancestors in all.
204 later devices descend from it; 13 cite it directly.
0 of 214 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.
- K954665: Glycar Staple Strips, Glycar, Inc. (1996) Summary page 1.
- K980483: Mentor Suspend Sling, Mentor Corp. (1998) Summary page 1.
- K963226: Surgical Fabrics, Boston Scientific Corp (1996) Summary page 1.

## Most influential descendants
- K001738: Depuy Restore Orthobiologic Soft Tissue Implant (2000), 173 descendants of its own
- K020049: Fortaflex Surgical Mesh (2002), 102 descendants of its own
- K031969: Depuy Restore Orthobiologic Soft Tissue Implant (2003), 91 descendants of its own
- K042809: Cuffpatch (2004), 72 descendants of its own
- K021056: Permacol (2002), 51 descendants of its own

## Indications for use
The Surgisis® Sling is intended for implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gastroenterological anatomy including but not limited to the following procedures: transvaginal repair of stress urinary incontinence, such as pubourethral support and bladder support, and transabdominal repair of apical vaginal prolapse, colon and rectal prolapse, and sacrecolposuspension. By providing pubourethral support, the sling may be used for the treatment of urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency. The device is supplied sterile and is intended for one-time use.

Source page: https://510kreport.com/device/K992159
Methodology: https://510kreport.com/methodology