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 Caldera Medical, Inc., Coloplast A/S and Coloplast Corp..

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 Apr 06, 2015
Vertessa Lite
K150016
Caldera Medical, Inc.
Obstetrics & Gynecology · 91d
Cleared Apr 06, 2015
Vertessa Lite Y-Mesh
K150023
Caldera Medical, Inc.
Obstetrics & Gynecology · 90d
Cleared Feb 12, 2014
RESTORELLE Y CONTOUR MESH
K140116
Coloplast A/S
Obstetrics & Gynecology · 27d
Cleared Aug 02, 2013
RESTORELLE M, RESTORELLE XL
K132061
Coloplast Corp.
Obstetrics & Gynecology · 30d
Cleared Apr 25, 2013
VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH
K123028
Caldera Medical, Inc.
Obstetrics & Gynecology · 209d
Cleared Mar 05, 2013
RESTORELLE Y CONTOUR
K123914
Coloplast A/S
Obstetrics & Gynecology · 76d
Cleared Feb 21, 2013
VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM
K123337
Caldera Medical
Obstetrics & Gynecology · 113d
Cleared Dec 18, 2012
UPSYLON Y MESH
K122794
Boston Scientific Corp
Obstetrics & Gynecology · 97d
Cleared Dec 18, 2012
NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015
K122968
Coloplast Corp.
Obstetrics & Gynecology · 84d
Cleared Nov 19, 2012
RESTORELLE L
K122440
Coloplast Corp.
Obstetrics & Gynecology · 101d
Cleared Oct 16, 2012
AMS LARGE PORE POLYPROPHLENE MESH
K121805
American Medical Systems
Obstetrics & Gynecology · 119d
Cleared Jun 11, 2012
ARTISYN Y-SHAPED MESH
K113205
Ethicon, Inc.
Obstetrics & Gynecology · 224d
Cleared May 17, 2012
RESTORELLE POLYPROPYLENE Y MESH
K112322
Coloplast A/S
Obstetrics & Gynecology · 279d
Cleared May 10, 2012
VERTESSA
K120327
Caldera Medical, Inc.
Obstetrics & Gynecology · 98d
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
Cleared Aug 03, 2005
AMS PELVIC FLOOR REPAIR SYSTEM
K051485
American Medical Systems, Inc.
Obstetrics & Gynecology · 58d
Cleared Jun 17, 2005
POLYFORM SYNTHETIC MESH
K051245
Proxy Biomedical , Ltd.
Obstetrics & Gynecology · 32d
Cleared Nov 17, 2004
MINIMESH POLYPROPYLENE MESH
K041632
Mpathy Medical Devices, Ltd.
Obstetrics & Gynecology · 154d
Cleared Apr 09, 2001
AMS SACRAL COLPOPEXY SLING, MODEL 72403501
K010931
American Medical Systems, Inc.
Obstetrics & Gynecology · 12d

About Product Code OTO - Regulatory Context