# K100936: Gynecare TVT Abbrevo Continence System

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Jul 1, 2010 after 87 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 K033568 (2003). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 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.

## Most influential descendants
- K181151: GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System (2018), 1 descendant of its own
- K201686: GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ Introducer and Catheter Guide, GYNECARE TVT EXACT™ Continence System and Trocar, GYNECARE TVT™ Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO™ Continence System and Passers and Winged Guide (2020), 0 descendants of its own
- K121928: Desara SL (2013), 0 descendants of its own

## Indications for use
The GYNECARE TVT ABBREVO™ Continence System is intended to be used 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/K100936
Methodology: https://510kreport.com/methodology