PWJ · Class II · 21 CFR 884.4910

FDA Product Code PWJ: Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence

Used To Aid In Insertion, Placement, Fixation, Or Anchoring Of Surgical Mesh For Stress Urinary Incontinence

Leading manufacturers include Ethicon, Inc., Boston Scientific Corporation and Caldera Medical, Inc..

5
Total
5
Cleared
203d
Avg days
2017
Since

FDA 510(k) Cleared Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence Devices (Product Code PWJ)

5 devices
1–5 of 5
Cleared Aug 10, 2018
GYNECARE TVT Abbrevo Continence System
K181151
Ethicon, Inc.
General & Plastic Surgery · 101d
Cleared Jul 06, 2018
GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar
K173019
Ethicon, Inc.
Gastroenterology & Urology · 281d
Cleared Jun 28, 2018
GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide
K173162
Ethicon, Inc.
Gastroenterology & Urology · 272d
Cleared May 04, 2018
Caldera Medical Transobturator Helical Introducer, Left
K172614
Caldera Medical, Inc.
Gastroenterology & Urology · 246d
Cleared Dec 20, 2017
Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device
K172565
Boston Scientific Corporation
Gastroenterology & Urology · 117d

About Product Code PWJ - Regulatory Context