PWK

Instrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse

Product code
PWK
Device name
Instrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse
Device class
Class 2
21 CFR
21 CFR 884.4910
Medical specialty
Obstetrics/Gynecology
Marketing pathway
510(K)
510(k) clearances (all years, FDA)
1 (all years; only the last 3 years are listed here)

FDA classification definition

Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for transabdominal pelvic organ prolapse repair

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: PWK
Classification and pathway per current FDA publications. Data from openFDA (CC0).