FDA 510(k) Applications for Medical Device Product Code "OTN"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K131229 | AMERICAN MEDICAL SYSTEMS | SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS | 12/05/2013 |
| K063713 | AMERICAN MEDICAL SYSTEMS, INC. | AMS SMART SLING SYSTEM | 02/22/2007 |
| K030123 | AMERICAN MEDICAL SYSTEMS, INC. | BIOARC SP SLING KIT | 02/06/2003 |
| K040538 | AMERICAN MEDICAL SYSTEMS, INC. | BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 72403996 | 03/17/2004 |
| K042592 | AMERICAN MEDICAL SYSTEMS, INC. | INTEMESH SILICONE-COATED SLING AND SURGICAL MESH WITH INHIBIZONE, MODEL 72403304 | 12/14/2004 |
| K020663 | AMERICAN MEDICAL SYSTEMS, INC. | MODIFICATION TO SPARC SLING SYSTEM | 03/28/2002 |
| K021263 | AMERICAN MEDICAL SYSTEMS, INC. | MODIFICATION TO SPARC SLING SYSTEM | 05/15/2002 |
| K051530 | AMERICAN MEDICAL SYSTEMS, INC. | MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193; MONARC C SUBFASCIAL HAMMOCK, MODEL 72404195. | 07/08/2005 |
| K023516 | AMERICAN MEDICAL SYSTEMS, INC. | MONARC SLING SYSTEM | 11/19/2002 |
| K132655 | AMERICAN MEDICAL SYSTEMS, INC. | RETROARC RETROPUBIC SLING SYSTEM | 11/20/2013 |
| K011251 | AMERICAN MEDICAL SYSTEMS, INC. | SPARC SLING SYSTEM | 08/01/2001 |
| K013355 | AMERICAN MEDICAL SYSTEMS, INC. | SPARC SLING SYSTEM | 10/26/2001 |
| K081613 | AMERICAN MEDICAL SYSTEMS, INC. | SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS | 09/17/2008 |
| K041948 | AMERICAN MEDICAL SYSTEMS, INC. | SPARC, MONARC, BIOARC SP AND BIOARC TO SLING SYSTEMS | 08/11/2004 |
| K210087 | Athena Surgical, LLC | Athena Surgical RMUS System | 04/12/2021 |
| K040787 | BOSTON SCIENTIFIC | MODIFICATION TO SURGICAL MESH POLYMERIC | 04/14/2004 |
| K020110 | BOSTON SCIENTIFIC | MODIFICATION TO TRELEX MESH SURGICAL MESH | 04/03/2002 |
| K121754 | BOSTON SCIENTIFIC CORP. | BLUE SUI SLING | 10/10/2012 |
| K231549 | Boston Scientific Corporation | Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System | 06/29/2023 |
| K211223 | Boston Scientific Corporation | Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System | 07/21/2021 |
| K093747 | C.R. BARD, INC. | ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS | 05/07/2010 |
| K070073 | C.R. BARD, INC. | ALIGN URETHRAL SUPPORT SYSTEM | 03/21/2007 |
| K140843 | CALDERA MEDICAL | DESARA BLUE OV, DESARA BLUE SS | 07/01/2014 |
| K112609 | CALDERA MEDICAL, INC. | DESARA MESH | 09/30/2011 |
| K101169 | CALDERA MEDICAL, INC. | DESARA MESH MODEL: CAL-DS01 | 05/20/2010 |
| K072456 | CALDERA MEDICAL, INC. | DESARA MESH SLING, MODEL CAL-DS01 | 05/08/2008 |
| K132069 | CALDERA MEDICAL, INC. | DESARA MESH, DESARA BLUE | 09/23/2013 |
| K121928 | CALDERA MEDICAL, INC. | DESARA SL | 02/19/2013 |
| K211975 | Caldera Medical, Inc. | 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 | 11/10/2021 |
| K162201 | CALDERA MEDICAL, INC. | Desara TV, Desara Blue TV | 01/11/2017 |
| K051533 | CL MEDICAL | I-STOP | 08/11/2005 |
| K111233 | COLOPLAST A/S | SUPRIS RETROPUBIC SLING SYSTEM | 06/24/2011 |
| K201686 | Ethicon Inc. | GYNECARE TVTÖ System, GYNECARE TVTÖ with Abdominal Guides System, GYNECARE TVTÖ Introducer and Catheter Guide, GYNECARE TVT EXACTÖ Continence System and Trocar, GYNECARE TVTÖ Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVOÖ Continence | 09/17/2020 |
| K100936 | ETHICON, INC. | GYNECARE TVT ABBREVO CONTINENCE SYSTEM | 07/01/2010 |
| K132054 | ETHICON, INC. | GYNECARE TVT EXACT CONTINENCE SYSTEM | 08/23/2013 |
| K100485 | ETHICON, INC. | GYNECARE TVT EXACT CONTINENCE SYSTEM | 03/16/2010 |
| K033568 | ETHICON, INC. | GYNECARE TVT OBTURATOR SYSTEM | 12/08/2003 |
| K974098 | ETHICON, INC. | PUBOUURETHRAL SLING | 01/28/1998 |
| K083471 | GENERIC MEDICAL DEVICE, INC. | GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020 | 03/03/2009 |
| K111219 | GENERIC MEDICAL DEVICE, INC. | GMD UNIVERSAL URINARY INCONTINENCE SLING | 06/30/2011 |
| K101440 | GENERIC MEDICAL DEVICES, INC. | GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012 | 06/18/2010 |
| K012628 | GYNECARE CENTER | GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM | 10/26/2001 |
| K050516 | HERNIAMESH S.R.L. | T-SLING | 02/03/2006 |
| K972651 | INFLUENCE, INC. | IN-SLING | 09/19/1997 |
| K980482 | INFLUENCE, INC. | TRIANGLE SLING | 03/27/1998 |
| K982042 | ISLAND BIOSURGICAL, INC. | ISLAND BIOSURGICAL BLADDER NECK BOLSTR MODEL IBIBOL.002 | 09/08/1998 |
| K960101 | ISLAND BIOSURGICAL, INC. | ISLAND BIOSURGICAL BOLSTER | 12/16/1996 |
| K973022 | ISLAND BIOSURGICAL, INC. | ISLAND BIOSURGICAL INC. BNS KIT #1 & #2 | 10/20/1997 |
| K042851 | MENTOR CORP. | MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT | 11/09/2004 |
| K031767 | MENTOR CORP. | MENTOR OBTAPE TRANS-OBTURATOR TAPE | 07/17/2003 |
| K053296 | MENTOR CORPORATION | MENTOR ARIS SUPRAPUBIC SURGICAL KIT | 12/15/2005 |
| K050148 | MENTOR CORPORATION | MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT | 03/09/2005 |
| K073647 | MPATHY MEDICAL DEVICES, LTD. | MINITAPE EXTRA URETHRAL SLING | 03/03/2008 |
| K092203 | MPATHY MEDICAL DEVICES, LTD. | OMNISURE URETHRAL SLING, MODEL OTK52 | 08/12/2009 |
| K103022 | NEOMEDIC INTERNATIONAL S.L. | KIM | 12/20/2011 |
| K020007 | PROMEDON | SAFYRE SLING SYSTEM | 03/21/2002 |
| K033691 | PROMEDON | SAFYRE VS AND SAFYRE T | 12/19/2003 |
| K012949 | SOFRADIM PRODUCTION | URETEX SUP PUBOURETHRAL SLING | 10/04/2001 |
| K041176 | SOFRADIM PRODUCTION | URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM | 05/17/2004 |
| K033310 | SPECIALITIES REMEEX INTERNATIONAL, S.L. | REMEEX SYSTEM FOR URINARY INCONTINENCE | 01/15/2004 |
| K020705 | TAG MEDICAL PRODUCTS | SIIS#1 TISSUE SUSPENSION SYSTEM | 04/26/2002 |
| K222293 | UroCure LLC | ArcSP Suprapubic Sling System | 09/21/2022 |
| K222468 | UroCure LLC | ArcTO Transobturator Sling System | 09/15/2022 |
| K183134 | UroCure LLC | ArcTV Transvaginal Sling System | 02/07/2019 |
| K052175 | UROPLASTY, INC. | I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000 | 10/17/2005 |
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