OTP · Class III · 21 CFR 884.5980

FDA Product Code OTP: Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

Tissue Reinforcement Of The Fibromuscular Layer Of The Pelvic Floor When Surgical Treatment Is Indicated; Procedures Include Anterior And Posterior Vaginal Wall Prolapse Repair And Vaginal Apical Or Uterine Prolapse Repair Performed Transvaginally

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

31
Total
31
Cleared
90d
Avg days
2003
Since

FDA 510(k) Cleared Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed Devices (Product Code OTP)

31 devices
1–24 of 31
Cleared Dec 13, 2012
PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM
K122459
Boston Scientific Corporation
Obstetrics & Gynecology · 122d
Cleared Sep 14, 2011
LITE PELVIC FLOOR REPAIR KITS
K103426
Boston Scientific Corp
Obstetrics & Gynecology · 296d
Cleared Jan 15, 2009
AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
K083839
C.R. Bard, Inc.
Obstetrics & Gynecology · 23d
Cleared Sep 30, 2008
AVAULTA SUPPORT SYSTEM
K082571
C.R. Bard, Inc.
Obstetrics & Gynecology · 25d
Cleared Aug 22, 2008
PINNACLE PELVIC FLOOR REPAIR KIT II
K081048
Boston Scientific Corp
Obstetrics & Gynecology · 130d
Cleared Nov 08, 2007
PINNACLE PELVIC FLOOR REPAIR KITS
K071957
Boston Scientific Corp
Obstetrics & Gynecology · 115d
Cleared Mar 12, 2007
AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
K063712
C.R. Bard, Inc.
Obstetrics & Gynecology · 88d

About Product Code OTP - Regulatory Context