OTO

Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

Product code

OTO

Device name

Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

Device class

Class 2

21 CFR

21 CFR 878.3300

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

Flag

Implant

510(k) clearances (all years, FDA)

23 (all years; only the last 3 years are listed here)

FDA classification definition

Bridging material to attach the vaginal apex to the anterior longitudinal ligament of the sacrum; Procedures include abdominal sacrocolpopexy and laparoscopic sacrocolpopexy.

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