PWI · Class II · 21 CFR 884.4910

FDA Product Code PWI: Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse

Used To Aid In Insertion, Placement, Fixation, Or Anchoring Of Surgical Mesh For Transvaginal Pelvic Organ Prolapse Repair

Leading manufacturers include Boston Scientific Corporation and Coloplast A/S.

2
Total
2
Cleared
105d
Avg days
2017
Since

FDA 510(k) Cleared Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse Devices (Product Code PWI)

2 devices
1–2 of 2
Cleared Feb 12, 2018
Digitex Delivery Device
K173527
Coloplast A/S
Obstetrics & Gynecology · 90d
Cleared Nov 03, 2017
Capio SLIM Suture Capturing Device
K172060
Boston Scientific Corporation
Obstetrics & Gynecology · 119d

About Product Code PWI - Regulatory Context