FDA 510(k) Applications for Medical Device Product Code: PWJ ()

FDA 510(k) Applications for Medical Device Product Code "PWJ"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K172565	Boston Scientific Corporation	Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device	12/20/2017
K172614	Caldera Medical, Inc.	Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medic	05/04/2018
K181151	Ethicon Inc	GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System	08/10/2018
K173019	Ethicon Inc.	GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar	07/06/2018
K173162	Ethicon, Inc	GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide	06/28/2018