# K111219: GMD Universal Urinary Incontinence Sling

- Pathway: 510(k) (Traditional)
- Applicant: Generic Medical Device, Inc.
- Decided: Jun 30, 2011 after 59 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: 11 generations back to K011251 (2001). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083471: GMD Universal Sling, Model Product Code 1010 and 1020, Generic Medical Device, Inc. (2009) Summary page 1.
- K101440: GMD Universal Urinary Incontinence Sling, Model 1012, Generic Medical Devices, Inc. (2010) Summary page 1.

## Indications for use
The GMD Universal Urinary Incontinence Sling-1011 is a suburethral sling indicated for use in women for treatment of stress urinary incontinence (SUI) resulting from either urethral hypermobility and/or intrinsic sphincter deficiency. The mesh is placed transvaginally using reusable introducers (sold separately) either through a transobturator or retropubic approach. The use of the device in males and children under 18 years of age is not supported by clinical studies.

Source page: https://510kreport.com/device/K111219
Methodology: https://510kreport.com/methodology