# K092203: Omnisure Urethral Sling, Model OTK52

- Pathway: 510(k) (Special)
- Applicant: Mpathy Medical Devices, Ltd.
- Decided: Aug 12, 2009 after 21 days
- Product code: OTN (Mesh, Surgical, 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: 9 generations back to K011251 (2001). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073647: Minitape Extra Urethral Sling, Mpathy Medical Devices, Ltd. (2008) Summary page 1.
- K011251: Sparc Sling System, American Medical Systems, Inc. (2001) Summary page 1.
- K013355: Sparc Sling System, American Medical Systems, Inc. (2001) Summary page 1.
- K021263: Modification to Sparc Sling System, American Medical Systems, Inc. (2002) Summary page 1.
- K020663: Modification to Sparc Sling System, American Medical Systems, Inc. (2002) Summary page 1.
- K974098: Pubouurethral Sling, ETHICON, Inc. (1998) Summary page 1.
- K091180: Minitape Urethral Sling, Mpathy Medical Devices, Ltd. (2009) Summary page 1.

## Indications for use
Omnisure™ Urethral Sling is indicated for the surgical treatment of urodynamically proven female urinary stress incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Source page: https://510kreport.com/device/K092203
Methodology: https://510kreport.com/methodology