ClearanceBrief
Panels › Obstetrics/Gynecology › Product code OTP · Class 3

Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

Regulation 884.5980

0510(k)s in 12 months (31 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
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Top companies in OTP

Company510(k)sRecalls
American Medical Systems130
Boston Scientific50
C.R. Bard, Inc.30
ETHICON, Inc.20
Sofradim Production20
Caldera Medical, Inc.10
Coloplast Corp.10
Coloplast A/S10
Mentor Corp.10
Mpathy Medical Devices, Inc.10
Decided510(k)Device and applicantCode
Dec 13, 2012K122459PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM
Boston Scientific Corporation
OTP
Jul 20, 2012K121612ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION
American Medical Systems
OTP
Oct 25, 2011K112842AMS ELEVATE PC
American Medical Systems, Inc.
OTP
Sep 14, 2011K103426LITE PELVIC FLOOR REPAIR KITS
Boston Scientific Corp
OTP
Sep 8, 2011K112386EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM
Coloplast Corp.
OTP
Jul 7, 2011K102815SURELIFT PROLAPSE SYSTEM
Neomedic International
OTP
Jul 1, 2011K111118AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
American Medical Systems
OTP
Aug 4, 2009K092207RESTORELLE POLYPROPYLENE MESH
Mpathy Medical Devices, Inc., GB
OTP
May 8, 2009K091131PELVIC FLOOR REPAIR SYSTEM
Boston Scientific
OTP
May 8, 2009K083499EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS
Coloplast A/S
OTP
Apr 2, 2009K090713ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP
American Medical Systems, Inc.
OTP
Mar 31, 2009K083722ASCEND
Caldera Medical, Inc.
OTP
Jan 15, 2009K083839AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
C.R. Bard, Inc.
OTP
Dec 23, 2008K082677AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
American Medical Systems, Inc.
OTP
Dec 4, 2008K082387APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM
American Medical Systems
OTP
Nov 26, 2008K082730AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE
American Medical Systems, Inc.
OTP
Oct 15, 2008K081710APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE
American Medical Systems
OTP
Sep 30, 2008K082571AVAULTA SUPPORT SYSTEM
C.R. Bard, Inc.
OTP
Aug 22, 2008K081048PINNACLE PELVIC FLOOR REPAIR KIT II
Boston Scientific Corp
OTP
May 15, 2008K071512GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS
ETHICON, Inc.
OTP
Apr 10, 2008K080185AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM
American Medical Systems, Inc.
OTP
Dec 19, 2007K072951PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES
Sofradim Production
OTP
Nov 8, 2007K071957PINNACLE PELVIC FLOOR REPAIR KITS
Boston Scientific Corp
OTP
Mar 12, 2007K063712AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
C.R. Bard, Inc.
OTP
Feb 26, 2007K063562GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS
ETHICON, Inc.
OTP
Dec 27, 2005K053414MENTOR NOVASILK MESH
Mentor Corp.
OTP
Aug 5, 2005K051503UGYTEX SUAL KNIT MESH
Sofradim Production
OTP
May 17, 2004K040623AMS PERIGEE SYSTEM
American Medical Systems, Inc.
OTP
Apr 22, 2004K040537AMS APOGEE VAULT SUSPENSION SYSTEM
American Medical Systems, Inc.
OTP
Mar 24, 2004K040521MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH
American Medical Systems, Inc.
OTP
Dec 31, 2003K033636AMS LARGE PORE POLYPROPYLENE MESH
American Medical Systems, Inc.
OTP

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