# K173162: GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Jun 28, 2018 after 272 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: 1 generation back to K012628 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012628: Gynecare Tension-Free Vaginal Tape System, Gynecare Center (2001) 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™ Abdominal Guides and Couplers are single use devices used to facilitate placement of the GYNECARE TVT™ device when placed in a top-down retropubic fashion (also known as an abdominal approach). The GYNECARE TVT™ Reusable Introducer is a reusable device intended to aid in the placement of the GYNECARE TVT™ device retropubically. The GYNECARE TVT™ Reusable Rigid Catheter Guide is a reusable device intended to facilitate the identification of the urethra and bladder neck during the placement of the GYNECARE TVT™ device.

Source page: https://510kreport.com/device/K173162
Methodology: https://510kreport.com/methodology