# K033568: Gynecare TVT Obturator System

- Pathway: 510(k) (Special)
- Applicant: ETHICON, Inc.
- Decided: Dec 8, 2003 after 26 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
No predicates in its family tree.
10 later devices descend from it; 6 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) GYNECARE TVT device: named in the summary without a submission number

## Most influential descendants
- K100936: Gynecare TVT Abbrevo Continence System (2010), 3 descendants of its own
- K083471: GMD Universal Sling, Model Product Code 1010 and 1020 (2009), 3 descendants of its own
- K181151: GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System (2018), 1 descendant of its own
- K101440: GMD Universal Urinary Incontinence Sling, Model 1012 (2010), 1 descendant of its own
- K051533: I-STOP (2005), 1 descendant of its own

## Indications for use
The GYNECARE TVT Obturator device is intended for use in women as a sub-urethral sling for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Source page: https://510kreport.com/device/K033568
Methodology: https://510kreport.com/methodology