PWI

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

Product code
PWI
Device name
Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal 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)
2 (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 transvaginal pelvic organ prolapse repair

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

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