# K020654: Stratasis Sling Kit

- Pathway: 510(k) (Traditional)
- Applicant: Cook Biotech, Inc.
- Decided: Apr 9, 2002 after 40 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). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 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 1.
- K974540: Sis Hernia Repair Device, Sentron Medical, Inc. (1998) Summary page 1.
- K974098: Pubouurethral Sling, ETHICON, Inc. (1998) Summary page 1.

## Indications for use
The STRATASIS™ Sling Kit is a sterile, single-use device intended to be used as a pubourethral sting indicated for treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Source page: https://510kreport.com/device/K020654
Methodology: https://510kreport.com/methodology