# K181151: GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Aug 10, 2018 after 101 days
- Product code: PWJ (Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence)
- Device class: 2
- Regulation: 21 CFR 884.4910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K033568 (2003). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100936: Gynecare TVT Abbrevo Continence System, ETHICON, Inc. (2010) Summary page 5.
- K033568: Gynecare TVT Obturator System, ETHICON, Inc. (2003) Summary page 5.

## Most influential descendants
- 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

## Indications for use
The Gynecare TVT ABBREVO™ Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT ABBREVO™ device. The Gynecare TVT™ Obturator Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT™ Obturator device.

Source page: https://510kreport.com/device/K181151
Methodology: https://510kreport.com/methodology