Atlas FDA

OTN

65 FDA 510(k) clearances · Product code

67 daysmedian time to decision
159 days90th percentile
65clearances measured

FDA profile

Official device name
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Device class
Class II (moderate risk)
Regulation
21 CFR 878.3300
Medical specialty
General, Plastic Surgery
Flags
Implant
FDA definition
Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility
Adverse events (MAUDE)
2021: 2,606 · 2022: 809 · 2023: 1,076 · 2024: 822 · 2025: 464 · 2026: 144
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System (K231549)Boston Scientific Corporation2023-06-29
ArcSP Suprapubic Sling System (K222293)Urocure, LLC2022-09-21
ArcTO Transobturator Sling System (K222468)Urocure, LLC2022-09-15
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 (K211975)Caldera Medical, Inc.2021-11-10
Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System (K211223)Boston Scientific Corporation2021-07-21
Athena Surgical RMUS System (K210087)Athena Surgical, LLC2021-04-12
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 (K201686)ETHICON, Inc.2020-09-17
ArcTV Transvaginal Sling System (K183134)Urocure, LLC2019-02-07
Desara TV, Desara Blue TV (K162201)Caldera Medical, Inc.2017-01-11
DESARA BLUE OV, DESARA BLUE SS (K140843)Caldera Medical2014-07-01
SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS (K131229)American Medical Systems2013-12-05
RETROARC RETROPUBIC SLING SYSTEM (K132655)American Medical Systems, Inc.2013-11-20
DESARA MESH, DESARA BLUE (K132069)Caldera Medical, Inc.2013-09-23
GYNECARE TVT EXACT CONTINENCE SYSTEM (K132054)ETHICON, Inc.2013-08-23
DESARA SL (K121928)Caldera Medical, Inc.2013-02-19
BLUE SUI SLING (K121754)Boston Scientific Corp2012-10-10
KIM (K103022)Neomedic International S.L.2011-12-20
DESARA MESH (K112609)Caldera Medical, Inc.2011-09-30
GMD UNIVERSAL URINARY INCONTINENCE SLING (K111219)Generic Medical Device, Inc.2011-06-30
SUPRIS RETROPUBIC SLING SYSTEM (K111233)Coloplast A/S2011-06-24
GYNECARE TVT ABBREVO CONTINENCE SYSTEM (K100936)ETHICON, Inc.2010-07-01
GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012 (K101440)Generic Medical Devices, Inc.2010-06-18
DESARA MESH MODEL: CAL-DS01 (K101169)Caldera Medical, Inc.2010-05-20
ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS (K093747)C.R. Bard, Inc.2010-05-07
GYNECARE TVT EXACT CONTINENCE SYSTEM (K100485)ETHICON, Inc.2010-03-16
OMNISURE URETHRAL SLING, MODEL OTK52 (K092203)Mpathy Medical Devices, Ltd.2009-08-12
GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020 (K083471)Generic Medical Device, Inc.2009-03-03
SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS (K081613)American Medical Systems, Inc.2008-09-17
DESARA MESH SLING, MODEL CAL-DS01 (K072456)Caldera Medical, Inc.2008-05-08
MINITAPE EXTRA URETHRAL SLING (K073647)Mpathy Medical Devices, Ltd.2008-03-03
ALIGN URETHRAL SUPPORT SYSTEM (K070073)C.R. Bard, Inc.2007-03-21
AMS SMART SLING SYSTEM (K063713)American Medical Systems, Inc.2007-02-22
T-SLING (K050516)Herniamesh S.R.L.2006-02-03
MENTOR ARIS SUPRAPUBIC SURGICAL KIT (K053296)Mentor Corporation2005-12-15
I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000 (K052175)Uroplasty, Inc.2005-10-17
I-STOP (K051533)Cl Medical2005-08-11
MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193; MONARC C SUBFASCIAL HAMMOCK, MODEL 72404195. (K051530)American Medical Systems, Inc.2005-07-08
MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT (K050148)Mentor Corporation2005-03-09
INTEMESH SILICONE-COATED SLING AND SURGICAL MESH WITH INHIBIZONE, MODEL 72403304 (K042592)American Medical Systems, Inc.2004-12-14
MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT (K042851)Mentor Corp.2004-11-09
SPARC, MONARC, BIOARC SP AND BIOARC TO SLING SYSTEMS (K041948)American Medical Systems, Inc.2004-08-11
URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM (K041176)Sofradim Production2004-05-17
MODIFICATION TO SURGICAL MESH POLYMERIC (K040787)Boston Scientific2004-04-14
BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 72403996 (K040538)American Medical Systems, Inc.2004-03-17
REMEEX SYSTEM FOR URINARY INCONTINENCE (K033310)Specialities Remeex International, S.L.2004-01-15
SAFYRE VS AND SAFYRE T (K033691)Promedon2003-12-19
GYNECARE TVT OBTURATOR SYSTEM (K033568)ETHICON, Inc.2003-12-08
MENTOR OBTAPE TRANS-OBTURATOR TAPE (K031767)Mentor Corp.2003-07-17
BIOARC SP SLING KIT (K030123)American Medical Systems, Inc.2003-02-06
MONARC SLING SYSTEM (K023516)American Medical Systems, Inc.2002-11-19
MODIFICATION TO SPARC SLING SYSTEM (K021263)American Medical Systems, Inc.2002-05-15
SIIS#1 TISSUE SUSPENSION SYSTEM (K020705)Tag Medical Products2002-04-26
MODIFICATION TO TRELEX MESH SURGICAL MESH (K020110)Boston Scientific2002-04-03
MODIFICATION TO SPARC SLING SYSTEM (K020663)American Medical Systems, Inc.2002-03-28
SAFYRE SLING SYSTEM (K020007)Promedon2002-03-21
GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM (K012628)Gynecare Center2001-10-26
SPARC SLING SYSTEM (K013355)American Medical Systems, Inc.2001-10-26
URETEX SUP PUBOURETHRAL SLING (K012949)Sofradim Production2001-10-04
SPARC SLING SYSTEM (K011251)American Medical Systems, Inc.2001-08-01
ISLAND BIOSURGICAL BLADDER NECK BOLSTR MODEL IBIBOL.002 (K982042)Island Biosurgical, Inc.1998-09-08
TRIANGLE SLING (K980482)Influence, Inc.1998-03-27
PUBOUURETHRAL SLING (K974098)ETHICON, Inc.1998-01-28
ISLAND BIOSURGICAL INC. BNS KIT #1 & #2 (K973022)Island Biosurgical, Inc.1997-10-20
IN-SLING (K972651)Influence, Inc.1997-09-19
ISLAND BIOSURGICAL BOLSTER (K960101)Island Biosurgical, Inc.1996-12-16

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Every clearance here is in the API, with alerts when new ones post.