# K083471: GMD Universal Sling, Model Product Code 1010 and 1020

- Pathway: 510(k) (Traditional)
- Applicant: Generic Medical Device, Inc.
- Decided: Mar 3, 2009 after 99 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K011251 (2001). 17 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033568: Gynecare TVT Obturator System, ETHICON, Inc. (2003) Summary page 1.
- K081275: Boston Scientific Surgical Mesh, Boston Scientific Corp (2008) Summary page 1.
- K072456: Desara Mesh Sling, Model Cal-DS01, Caldera Medical, Inc. (2008) Summary page 2.

## Most influential descendants
- K101440: GMD Universal Urinary Incontinence Sling, Model 1012 (2010), 1 descendant of its own
- K103022: KIM (2011), 0 descendants of its own
- K111219: GMD Universal Urinary Incontinence Sling (2011), 0 descendants of its own

## Recalls of this device
- Feb 14, 2011 · Not classified · Z-1390-2011: Protective sheath sticks to itself and sleeve breakage has resulted in complaints and MDRs.
- Jun 18, 2009 · Not classified · Z-0268-2010: Product that is approved only for use outside the U.S. was shipped to two customers in the U.S.

## Indications for use
The GMD Universal Sling 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.

Source page: https://510kreport.com/device/K083471
Methodology: https://510kreport.com/methodology