Panels › General, Plastic Surgery › Product code OTN · Class 2
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Regulation 878.3300
1510(k)s in 12 months (66 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in OTN
| Company | 510(k)s | Recalls |
|---|---|---|
| American Medical Systems | 14 | 1 |
| Caldera Medical | 8 | 0 |
| ETHICON, Inc. | 6 | 0 |
| Boston Scientific | 5 | 0 |
| Mentor Corp. | 4 | 0 |
| Island Biosurgical, Inc. | 3 | 0 |
| Urocure, LLC | 3 | 0 |
| C.R. Bard, Inc. | 2 | 0 |
| Generic Medical Device, Inc. | 2 | 0 |
| Influence, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 16, 2026 | K262284 | KIM BLUE Desarrollo e Investigación Médica Aragonesa S.L., ES | OTN |
| Jun 29, 2023 | K231549 | Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System Boston Scientific Corporation | OTN |
| Sep 21, 2022 | K222293 | ArcSP Suprapubic Sling System Urocure, LLC | OTN |
| Sep 15, 2022 | K222468 | ArcTO Transobturator Sling System Urocure, LLC | OTN |
| Nov 10, 2021 | K211975 | 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 Caldera Medical, Inc. | OTN |
| Jul 21, 2021 | K211223 | Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System Boston Scientific Corporation | OTN |
| Apr 12, 2021 | K210087 | Athena Surgical RMUS System Athena Surgical, LLC | OTN |
| Sep 17, 2020 | K201686 | GYNECARE TVT System, GYNECARE TVT with Abdominal Guides System, GYNECARE TVT Introducer and Catheter Guide, GYNECARE ETHICON, Inc. | OTN |
| Feb 7, 2019 | K183134 | ArcTV Transvaginal Sling System Urocure, LLC | OTN |
| Jan 11, 2017 | K162201 | Desara TV, Desara Blue TV Caldera Medical, Inc. | OTN |
| Jul 1, 2014 | K140843 | DESARA BLUE OV, DESARA BLUE SS Caldera Medical | OTN |
| Dec 5, 2013 | K131229 | SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS American Medical Systems | OTN |
| Nov 20, 2013 | K132655 | RETROARC RETROPUBIC SLING SYSTEM American Medical Systems, Inc. | OTN |
| Sep 23, 2013 | K132069 | DESARA MESH, DESARA BLUE Caldera Medical, Inc. | OTN |
| Aug 23, 2013 | K132054 | GYNECARE TVT EXACT CONTINENCE SYSTEM ETHICON, Inc. | OTN |
| Feb 19, 2013 | K121928 | DESARA SL Caldera Medical, Inc. | OTN |
| Oct 10, 2012 | K121754 | BLUE SUI SLING Boston Scientific Corp | OTN |
| Dec 20, 2011 | K103022 | KIM Neomedic International S.L. | OTN |
| Sep 30, 2011 | K112609 | DESARA MESH Caldera Medical, Inc. | OTN |
| Jun 30, 2011 | K111219 | GMD UNIVERSAL URINARY INCONTINENCE SLING Generic Medical Device, Inc. | OTN |
| Jun 24, 2011 | K111233 | SUPRIS RETROPUBIC SLING SYSTEM Coloplast A/S | OTN |
| Jul 1, 2010 | K100936 | GYNECARE TVT ABBREVO CONTINENCE SYSTEM ETHICON, Inc. | OTN |
| Jun 18, 2010 | K101440 | GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012 Generic Medical Devices, Inc. | OTN |
| May 20, 2010 | K101169 | DESARA MESH MODEL: CAL-DS01 Caldera Medical, Inc. | OTN |
| May 7, 2010 | K093747 | ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS C.R. Bard, Inc. | OTN |
| Mar 16, 2010 | K100485 | GYNECARE TVT EXACT CONTINENCE SYSTEM ETHICON, Inc. | OTN |
| Aug 12, 2009 | K092203 | OMNISURE URETHRAL SLING, MODEL OTK52 Mpathy Medical Devices, Ltd., GB | OTN |
| Mar 3, 2009 | K083471 | GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020 Generic Medical Device, Inc. | OTN |
| Sep 17, 2008 | K081613 | SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS American Medical Systems, Inc. | OTN |
| May 8, 2008 | K072456 | DESARA MESH SLING, MODEL CAL-DS01 Caldera Medical, Inc. | OTN |
| Mar 3, 2008 | K073647 | MINITAPE EXTRA URETHRAL SLING Mpathy Medical Devices, Ltd. | OTN |
| Mar 21, 2007 | K070073 | ALIGN URETHRAL SUPPORT SYSTEM C.R. Bard, Inc. | OTN |
| Feb 22, 2007 | K063713 | AMS SMART SLING SYSTEM American Medical Systems, Inc. | OTN |
| Feb 3, 2006 | K050516 | T-SLING Herniamesh S.R.L., IT | OTN |
| Dec 15, 2005 | K053296 | MENTOR ARIS SUPRAPUBIC SURGICAL KIT Mentor Corporation | OTN |
| Oct 17, 2005 | K052175 | I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000 Uroplasty, Inc. | OTN |
| Aug 11, 2005 | K051533 | I-STOP Cl Medical, FR | OTN |
| Jul 8, 2005 | K051530 | MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193; MONARC C SUBFASCIAL HAMMOCK, MODEL 72404195. American Medical Systems, Inc. | OTN |
| Mar 9, 2005 | K050148 | MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT Mentor Corporation | OTN |
| Dec 14, 2004 | K042592 | INTEMESH SILICONE-COATED SLING AND SURGICAL MESH WITH INHIBIZONE, MODEL 72403304 American Medical Systems, Inc. | OTN |
| Nov 9, 2004 | K042851 | MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT Mentor Corp. | OTN |
| Aug 11, 2004 | K041948 | SPARC, MONARC, BIOARC SP AND BIOARC TO SLING SYSTEMS American Medical Systems, Inc. | OTN |
| May 17, 2004 | K041176 | URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM Sofradim Production | OTN |
| Apr 14, 2004 | K040787 | MODIFICATION TO SURGICAL MESH POLYMERIC Boston Scientific | OTN |
| Mar 17, 2004 | K040538 | BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 72403996 American Medical Systems, Inc. | OTN |
| Jan 15, 2004 | K033310 | REMEEX SYSTEM FOR URINARY INCONTINENCE Specialities Remeex International, S.L. | OTN |
| Dec 19, 2003 | K033691 | SAFYRE VS AND SAFYRE T Promedon | OTN |
| Dec 8, 2003 | K033568 | GYNECARE TVT OBTURATOR SYSTEM ETHICON, Inc. | OTN |
| Jul 17, 2003 | K031767 | MENTOR OBTAPE TRANS-OBTURATOR TAPE Mentor Corp. | OTN |
| Feb 6, 2003 | K030123 | BIOARC SP SLING KIT American Medical Systems, Inc. | OTN |
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