PWK · Class II · 21 CFR 884.4910

FDA Product Code PWK: Instrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse

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

Leading manufacturers include Coloplast.

1
Total
1
Cleared
88d
Avg days
2018
Since

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

1 devices
1–1 of 1
Cleared Feb 09, 2018
Meridian Vaginal Positioning System (VPS)
K173501
Coloplast
Obstetrics & Gynecology · 88d

About Product Code PWK - Regulatory Context