# K101440: GMD Universal Urinary Incontinence Sling, Model 1012

- Pathway: 510(k) (Special)
- Applicant: Generic Medical Devices, Inc.
- Decided: Jun 18, 2010 after 25 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: 10 generations back to K011251 (2001). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
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.
- K072456: Desara Mesh Sling, Model Cal-DS01, Caldera Medical, Inc. (2008) Summary page 1.

## Most influential descendants
- K111219: GMD Universal Urinary Incontinence Sling (2011), 0 descendants of its own

## Indications for use
The GMD Universal Urinary Incontinence Sling™-1012 is indicated for use in women as a suburethral sling for the treatment of Stress Urinary incontinence (SUI) resulting from either urethral hypermobility and/or intrinsic sphincter deficiency. 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/K101440
Methodology: https://510kreport.com/methodology