Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

FDA product code OTN · 64 cleared devices

Class 2 General, Plastic Surgery

Regulation: 21 CFR 878.3300
Review panel: GU
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1996-12-16 – 2023-06-29

Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility

OTN 2023-06-29

Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System

Applicant Boston Scientific Corporation

K number K231549

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OTN 2022-09-21

ArcSP Suprapubic Sling System

Applicant Urocure, LLC

K number K222293

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OTN 2022-09-15

ArcTO Transobturator Sling System

Applicant Urocure, LLC

K number K222468

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OTN 2021-11-10

Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System

Applicant Caldera Medical, Inc.

K number K211975

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OTN 2021-07-21

Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System

Applicant Boston Scientific Corporation

K number K211223

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OTN 2021-04-12

Athena Surgical RMUS System

Applicant Athena Surgical, LLC

K number K210087

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OTN 2020-09-17

GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ Introducer and Catheter Guide, GYNECARE TVT EXACT™ Continence System and Trocar, GYNECARE TVT™ Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO™ Continence System and Passers and Winged Guide

Applicant ETHICON, Inc.

K number K201686

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OTN 2019-02-07

ArcTV Transvaginal Sling System

Applicant Urocure, LLC

K number K183134

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OTN 2017-01-11

Desara TV, Desara Blue TV

Applicant Caldera Medical, Inc.

K number K162201

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OTN 2013-12-05

SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS

Applicant American Medical Systems

K number K131229

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OTN 2013-11-20

RETROARC RETROPUBIC SLING SYSTEM

Applicant American Medical Systems, Inc.

K number K132655

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OTN 2013-09-23

DESARA MESH, DESARA BLUE

Applicant Caldera Medical, Inc.

K number K132069

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OTN 2013-08-23

GYNECARE TVT EXACT CONTINENCE SYSTEM

Applicant ETHICON, Inc.

K number K132054

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OTN 2013-02-19

DESARA SL

Applicant Caldera Medical, Inc.

K number K121928

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OTN 2012-10-10

BLUE SUI SLING

Applicant Boston Scientific Corp

K number K121754

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OTN 2011-12-20

KIM

Applicant Neomedic International S.L.

K number K103022

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OTN 2011-09-30

DESARA MESH

Applicant Caldera Medical, Inc.

K number K112609

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OTN 2011-06-30

GMD UNIVERSAL URINARY INCONTINENCE SLING

Applicant Generic Medical Device, Inc.

K number K111219

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OTN 2011-06-24

SUPRIS RETROPUBIC SLING SYSTEM

Applicant Coloplast A/S

K number K111233

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OTN 2010-07-01

GYNECARE TVT ABBREVO CONTINENCE SYSTEM

Applicant ETHICON, Inc.

K number K100936

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OTN 2010-06-18

GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012

Applicant Generic Medical Devices, Inc.

K number K101440

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OTN 2010-05-20

DESARA MESH MODEL: CAL-DS01

Applicant Caldera Medical, Inc.

K number K101169

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OTN 2010-05-07

ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS

Applicant C.R. Bard, Inc.

K number K093747

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OTN 2010-03-16

GYNECARE TVT EXACT CONTINENCE SYSTEM

Applicant ETHICON, Inc.

K number K100485

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OTN 2009-08-12

OMNISURE URETHRAL SLING, MODEL OTK52

Applicant Mpathy Medical Devices, Ltd.

K number K092203

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OTN 2009-03-03

GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020

Applicant Generic Medical Device, Inc.

K number K083471

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OTN 2008-09-17

SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS

Applicant American Medical Systems, Inc.

K number K081613

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OTN 2008-05-08

DESARA MESH SLING, MODEL CAL-DS01

Applicant Caldera Medical, Inc.

K number K072456

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OTN 2008-03-03

MINITAPE EXTRA URETHRAL SLING

Applicant Mpathy Medical Devices, Ltd.

K number K073647

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OTN 2007-03-21

ALIGN URETHRAL SUPPORT SYSTEM

Applicant C.R. Bard, Inc.

K number K070073

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OTN 2007-02-22

AMS SMART SLING SYSTEM

Applicant American Medical Systems, Inc.

K number K063713

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OTN 2006-02-03

T-SLING

Applicant Herniamesh S.R.L.

K number K050516

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OTN 2005-12-15

MENTOR ARIS SUPRAPUBIC SURGICAL KIT

Applicant Mentor Corporation

K number K053296

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OTN 2005-10-17

I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000

Applicant Uroplasty, Inc.

K number K052175

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OTN 2005-08-11

I-STOP

Applicant Cl Medical

K number K051533

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OTN 2005-07-08

MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193; MONARC C SUBFASCIAL HAMMOCK, MODEL 72404195.

Applicant American Medical Systems, Inc.

K number K051530

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OTN 2005-03-09

MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT

Applicant Mentor Corporation

K number K050148

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OTN 2004-12-14

INTEMESH SILICONE-COATED SLING AND SURGICAL MESH WITH INHIBIZONE, MODEL 72403304

Applicant American Medical Systems, Inc.

K number K042592

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OTN 2004-11-09

MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT

Applicant Mentor Corp.

K number K042851

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OTN 2004-08-11

SPARC, MONARC, BIOARC SP AND BIOARC TO SLING SYSTEMS

Applicant American Medical Systems, Inc.

K number K041948

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OTN 2004-05-17

URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM

Applicant Sofradim Production

K number K041176

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OTN 2004-04-14

MODIFICATION TO SURGICAL MESH POLYMERIC

Applicant Boston Scientific

K number K040787

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OTN 2004-03-17

BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 72403996

Applicant American Medical Systems, Inc.

K number K040538

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OTN 2004-01-15

REMEEX SYSTEM FOR URINARY INCONTINENCE

Applicant Specialities Remeex International, S.L.

K number K033310

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OTN 2003-12-19

SAFYRE VS AND SAFYRE T

Applicant Promedon

K number K033691

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OTN 2003-12-08

GYNECARE TVT OBTURATOR SYSTEM

Applicant ETHICON, Inc.

K number K033568

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OTN 2003-07-17

MENTOR OBTAPE TRANS-OBTURATOR TAPE

Applicant Mentor Corp.

K number K031767

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OTN 2003-02-06

BIOARC SP SLING KIT

Applicant American Medical Systems, Inc.

K number K030123

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OTN 2002-11-19

MONARC SLING SYSTEM

Applicant American Medical Systems, Inc.

K number K023516

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OTN 2002-05-15

MODIFICATION TO SPARC SLING SYSTEM

Applicant American Medical Systems, Inc.

K number K021263

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OTN 2002-04-26

SIIS#1 TISSUE SUSPENSION SYSTEM

Applicant Tag Medical Products

K number K020705

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OTN 2002-04-03

MODIFICATION TO TRELEX MESH SURGICAL MESH

Applicant Boston Scientific

K number K020110

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OTN 2002-03-28

MODIFICATION TO SPARC SLING SYSTEM

Applicant American Medical Systems, Inc.

K number K020663

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OTN 2002-03-21

SAFYRE SLING SYSTEM

Applicant Promedon

K number K020007

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OTN 2001-10-26

SPARC SLING SYSTEM

Applicant American Medical Systems, Inc.

K number K013355

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OTN 2001-10-26

GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM

Applicant Gynecare Center

K number K012628

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OTN 2001-10-04

URETEX SUP PUBOURETHRAL SLING

Applicant Sofradim Production

K number K012949

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OTN 2001-08-01

SPARC SLING SYSTEM

Applicant American Medical Systems, Inc.

K number K011251

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OTN 1998-09-08

ISLAND BIOSURGICAL BLADDER NECK BOLSTR MODEL IBIBOL.002

Applicant Island Biosurgical, Inc.

K number K982042

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OTN 1998-03-27

TRIANGLE SLING

Applicant Influence, Inc.

K number K980482

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OTN 1998-01-28

PUBOUURETHRAL SLING

Applicant ETHICON, Inc.

K number K974098

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OTN 1997-10-20

ISLAND BIOSURGICAL INC. BNS KIT #1 & #2

Applicant Island Biosurgical, Inc.

K number K973022

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OTN 1997-09-19

IN-SLING

Applicant Influence, Inc.

K number K972651

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OTN 1996-12-16

ISLAND BIOSURGICAL BOLSTER

Applicant Island Biosurgical, Inc.

K number K960101

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