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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