# K050516: T-Sling

- Pathway: 510(k) (Traditional)
- Applicant: Herniamesh S.R.L.
- Decided: Feb 3, 2006 after 339 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: 2 generations back to K974098 (1998). 5 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020652: Herniamesh T-Sling, Herniamesh (2002) Summary page 1.
- K010035: Ivs Tunneller, United States Surgical, A Division of Tyco Healthc (2001)
- K012628: Gynecare Tension-Free Vaginal Tape System, Gynecare Center (2001) Summary page 1.

## Most influential descendants
- K072456: Desara Mesh Sling, Model Cal-DS01 (2008), 10 descendants of its own
- K101169: Desara Mesh Model: Cal-DS01 (2010), 5 descendants of its own
- K112609: Desara Mesh (2011), 3 descendants of its own
- K083471: GMD Universal Sling, Model Product Code 1010 and 1020 (2009), 3 descendants of its own
- K132069: Desara Mesh, Desara Blue (2013), 1 descendant of its own

## Indications for use
The T-sling is intended to be used in females to position a polypropylene mesh for treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

Source page: https://510kreport.com/device/K050516
Methodology: https://510kreport.com/methodology