# K091180: Minitape Urethral Sling

- Pathway: 510(k) (Special)
- Applicant: Mpathy Medical Devices, Ltd.
- Decided: Jul 14, 2009 after 82 days
- Product code: PAH (Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling)
- 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: 8 generations back to K011251 (2001). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073646: Minitape Urethral Sling, Mpathy Medical Devices, Ltd. (2008) Summary page 1.
- K020007: Safyre Sling System, Promedon (2002) Summary page 1.
- K033310: Remeex System for Urinary Incontinence, Specialities Remeex International, S.L. (2004) 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.
- K052401: Gynecare TVT Secur System, ETHICON, Inc. (2005) Summary page 1.
- K073703: Ams Miniarc Sling System, American Medical Systems, Inc. (2008) Summary page 1.

## Most influential descendants
- K092203: Omnisure Urethral Sling, Model OTK52 (2009), 0 descendants of its own

## Indications for use
Minitape 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/K091180
Methodology: https://510kreport.com/methodology