OTO · Class II · 21 CFR 878.3300

FDA Product Code OTO: Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

Bridging Material To Attach The Vaginal Apex To The Anterior Longitudinal Ligament Of The Sacrum; Procedures Include Abdominal Sacrocolpopexy And Laparoscopic Sacrocolpopexy.

Leading manufacturers include C.R. Bard, Inc., Boston Scientific Corp and Boston Scientific Corporation.

23
Total
23
Cleared
120d
Avg days
2001
Since

FDA 510(k) Cleared Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed Devices (Product Code OTO)

23 devices
1–23 of 23
Cleared Dec 15, 2017
Polyform Synthetic Mesh
K171271
Boston Scientific Corporation
Obstetrics & Gynecology · 228d
Cleared Dec 18, 2012
UPSYLON Y MESH
K122794
Boston Scientific Corp
Obstetrics & Gynecology · 97d
Cleared Apr 01, 2011
ALYTE Y-MESH GRAFT
K101722
C.R. Bard, Inc.
Obstetrics & Gynecology · 287d
Cleared Nov 10, 2009
BARD SACROCOLPOPEXY GRAFT
K090739
C.R. Bard, Inc.
Obstetrics & Gynecology · 235d

About Product Code OTO - Regulatory Context