# K041176: Uretex to Trans-Obturator Urethral Support System

- Pathway: 510(k) (Special)
- Applicant: Sofradim Production
- Decided: May 17, 2004 after 12 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: 1 generation back to K974098 (1998). 3 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974098: Pubouurethral Sling, ETHICON, Inc. (1998) Summary page 1.
- K991400: Parietene Polypropylene Mesh, Sofradim Production (1999) Summary page 1.
- K980483: Mentor Suspend Sling, Mentor Corp. (1998) Summary page 1.

## Most influential descendants
- K070073: Align Urethral Support System (2007), 1 descendant of its own
- K051533: I-STOP (2005), 1 descendant of its own
- K093747: Align and Align to Urethral Support Systems (2010), 0 descendants of its own
- K063079: I-Stop Trans Obturator Male Sling (2006), 0 descendants of its own

## Indications for use
The URETEX® TO Trans-Obturator Urethral Support System is indicated for the treatment of female stress urinary incontinence from urethral hyper mobility and/or intrinsic sphincter deficiency.

Source page: https://510kreport.com/device/K041176
Methodology: https://510kreport.com/methodology