# K100485: Gynecare TVT Exact Continence System

- Pathway: 510(k) (Special)
- Applicant: ETHICON, Inc.
- Decided: Mar 16, 2010 after 25 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). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 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.

## Most influential descendants
- K132054: Gynecare TVT Exact Continence System (2013), 3 descendants of its own
- K173019: GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar (2018), 1 descendant of its own
- K210087: Athena Surgical RMUS System (2021), 0 descendants 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

## Indications for use
The GYNECARE TVT EXACT™ Continence System is intended to be used as a pubourethral sling for treatment of female Stress Urinary Incontinence, resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Source page: https://510kreport.com/device/K100485
Methodology: https://510kreport.com/methodology