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 American Medical Systems, Inc., American Medical Systems and C.R. Bard, Inc..

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 Jul 20, 2012
ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION
K121612
American Medical Systems
Obstetrics & Gynecology · 49d
Cleared Oct 25, 2011
AMS ELEVATE PC
K112842
American Medical Systems, Inc.
Obstetrics & Gynecology · 26d
Cleared Sep 14, 2011
LITE PELVIC FLOOR REPAIR KITS
K103426
Boston Scientific Corp
Obstetrics & Gynecology · 296d
Cleared Sep 08, 2011
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM
K112386
Coloplast Corp.
Obstetrics & Gynecology · 21d
Cleared Jul 07, 2011
SURELIFT PROLAPSE SYSTEM
K102815
Neomedic International
Obstetrics & Gynecology · 282d
Cleared Jul 01, 2011
AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
K111118
American Medical Systems
Obstetrics & Gynecology · 71d
Cleared Aug 04, 2009
RESTORELLE POLYPROPYLENE MESH
K092207
Mpathy Medical Devices, Inc.
Obstetrics & Gynecology · 13d
Cleared May 08, 2009
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS
K083499
Coloplast A/S
Obstetrics & Gynecology · 164d
Cleared May 08, 2009
PELVIC FLOOR REPAIR SYSTEM
K091131
Boston Scientific
Obstetrics & Gynecology · 18d
Cleared Apr 02, 2009
ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP
K090713
American Medical Systems, Inc.
Obstetrics & Gynecology · 15d
Cleared Mar 31, 2009
ASCEND
K083722
Caldera Medical, Inc.
Obstetrics & Gynecology · 106d
Cleared Jan 15, 2009
AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
K083839
C.R. Bard, Inc.
Obstetrics & Gynecology · 23d
Cleared Dec 23, 2008
AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
K082677
American Medical Systems, Inc.
Obstetrics & Gynecology · 99d
Cleared Dec 04, 2008
APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS
K082387
American Medical Systems
Obstetrics & Gynecology · 107d
Cleared Nov 26, 2008
AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE
K082730
American Medical Systems, Inc.
Obstetrics & Gynecology · 69d
Cleared Oct 15, 2008
APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE
K081710
American Medical Systems
Obstetrics & Gynecology · 120d
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 May 15, 2008
GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS
K071512
Ethicon, Inc.
Obstetrics & Gynecology · 346d
Cleared Apr 10, 2008
AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM
K080185
American Medical Systems, Inc.
Obstetrics & Gynecology · 76d
Cleared Dec 19, 2007
PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES
K072951
Sofradim Production
Obstetrics & Gynecology · 62d
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