# K132054: Gynecare TVT Exact Continence System

- Pathway: 510(k) (Special)
- Applicant: ETHICON, Inc.
- Decided: Aug 23, 2013 after 51 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: 2 generations back to K974098 (1998). 2 ancestors in all.
3 later devices descend from it; 3 cite 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)
- K100485: Gynecare TVT Exact Continence System, ETHICON, Inc. (2010). Our reading of the summary gave K110485, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “GYNECARE TVT EXACT Continence System”. Summary page 1.

## Most influential descendants
- 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 EXACr-M Continence System is intended to be used as a pubourethral sling for treatment of female Stress Urinary Incontinence, resulting from urethra; hypermobility and/or intrinsic sphincter deficiency.

Source page: https://510kreport.com/device/K132054
Methodology: https://510kreport.com/methodology