510(k) Report

Devices descending from K100485

4 later devices reach Gynecare TVT Exact Continence System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132054Gynecare TVT Exact Continence SystemETHICON, Inc.20133—
+2K210087Athena Surgical RMUS SystemAthena Surgical, LLC20210—
+2K201686GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™…ETHICON, Inc.20200—
+2K173019GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE…ETHICON, Inc.20181—