Product Code: OTN FDA class 2 21 CFR 878.3300

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

General, Plastic Surgery

The Mesh, Surgical, Synthetic, Urogynecologic, for Stress Urinary Incontinence, Retropubic or Transobturator (product code OTN) is an implantable synthetic mesh used for the surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency and/or urethral hypermobility. It is placed via retropubic or transobturator approaches to provide a mid-urethral sling. As an FDA Class 2 device under regulation 878.3300, it requires 510(k) premarket clearance and falls within the General and Plastic Surgery specialty, reviewed by the Urology panel. The device is flagged as an implant and is not life-sustaining.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: OTN
Device Class: FDA class 2
Regulation Number: 878.3300
Medical Specialty: General, Plastic Surgery
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Definition

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

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 65 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K231549	Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System	Jun 29, 2023	Substantially Equivalent	Boston Scientific Corporation
K222293	ArcSP Suprapubic Sling System	Sep 21, 2022	Substantially Equivalent	Urocure, LLC
K222468	ArcTO Transobturator Sling System	Sep 15, 2022	Substantially Equivalent	Urocure, LLC
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	Nov 10, 2021	Substantially Equivalent	Caldera Medical, Inc.
K211223	Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System	Jul 21, 2021	Substantially Equivalent	Boston Scientific Corporation
K210087	Athena Surgical RMUS System	Apr 12, 2021	Substantially Equivalent	Athena Surgical, LLC
K201686	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	Sep 17, 2020	Substantially Equivalent	ETHICON, Inc.
K183134	ArcTV Transvaginal Sling System	Feb 07, 2019	Substantially Equivalent	Urocure, LLC
K162201	Desara TV, Desara Blue TV	Jan 11, 2017	Substantially Equivalent	Caldera Medical, Inc.
K140843	DESARA BLUE OV, DESARA BLUE SS	Jul 01, 2014	Substantially Equivalent	Caldera Medical
K131229	SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS	Dec 05, 2013	Substantially Equivalent	American Medical Systems
K132655	RETROARC RETROPUBIC SLING SYSTEM	Nov 20, 2013	Substantially Equivalent	American Medical Systems, Inc.
K132069	DESARA MESH, DESARA BLUE	Sep 23, 2013	Substantially Equivalent	Caldera Medical, Inc.
K132054	GYNECARE TVT EXACT CONTINENCE SYSTEM	Aug 23, 2013	Substantially Equivalent	ETHICON, Inc.
K121928	DESARA SL	Feb 19, 2013	Substantially Equivalent	Caldera Medical, Inc.
K121754	BLUE SUI SLING	Oct 10, 2012	Substantially Equivalent	Boston Scientific Corp
K103022	KIM	Dec 20, 2011	Substantially Equivalent	Neomedic International S.L.
K112609	DESARA MESH	Sep 30, 2011	Substantially Equivalent	Caldera Medical, Inc.
K111219	GMD UNIVERSAL URINARY INCONTINENCE SLING	Jun 30, 2011	Substantially Equivalent	Generic Medical Device, Inc.
K111233	SUPRIS RETROPUBIC SLING SYSTEM	Jun 24, 2011	Substantially Equivalent	Coloplast A/S
K100936	GYNECARE TVT ABBREVO CONTINENCE SYSTEM	Jul 01, 2010	Substantially Equivalent	ETHICON, Inc.
K101440	GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012	Jun 18, 2010	Substantially Equivalent	Generic Medical Devices, Inc.
K101169	DESARA MESH MODEL: CAL-DS01	May 20, 2010	Substantially Equivalent	Caldera Medical, Inc.
K093747	ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS	May 07, 2010	Substantially Equivalent	C.R. Bard, Inc.
K100485	GYNECARE TVT EXACT CONTINENCE SYSTEM	Mar 16, 2010	Substantially Equivalent	ETHICON, Inc.
K092203	OMNISURE URETHRAL SLING, MODEL OTK52	Aug 12, 2009	Substantially Equivalent	Mpathy Medical Devices, Ltd.
K083471	GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020	Mar 03, 2009	Substantially Equivalent	Generic Medical Device, Inc.
K081613	SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS	Sep 17, 2008	Substantially Equivalent	American Medical Systems, Inc.
K072456	DESARA MESH SLING, MODEL CAL-DS01	May 08, 2008	Substantially Equivalent	Caldera Medical, Inc.
K073647	MINITAPE EXTRA URETHRAL SLING	Mar 03, 2008	Substantially Equivalent	Mpathy Medical Devices, Ltd.
K070073	ALIGN URETHRAL SUPPORT SYSTEM	Mar 21, 2007	Substantially Equivalent	C.R. Bard, Inc.
K063713	AMS SMART SLING SYSTEM	Feb 22, 2007	Substantially Equivalent	American Medical Systems, Inc.
K050516	T-SLING	Feb 03, 2006	Substantially Equivalent	Herniamesh S.R.L.
K053296	MENTOR ARIS SUPRAPUBIC SURGICAL KIT	Dec 15, 2005	Substantially Equivalent	Mentor Corporation
K052175	I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000	Oct 17, 2005	Substantially Equivalent	Uroplasty, Inc.
K051533	I-STOP	Aug 11, 2005	Substantially Equivalent	Cl Medical
K051530	MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193; MONARC C SUBFASCIAL HAMMOCK, MODEL 72404195.	Jul 08, 2005	Substantially Equivalent	American Medical Systems, Inc.
K050148	MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT	Mar 09, 2005	Substantially Equivalent	Mentor Corporation
K042592	INTEMESH SILICONE-COATED SLING AND SURGICAL MESH WITH INHIBIZONE, MODEL 72403304	Dec 14, 2004	Substantially Equivalent	American Medical Systems, Inc.
K042851	MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT	Nov 09, 2004	Substantially Equivalent	Mentor Corp.
K041948	SPARC, MONARC, BIOARC SP AND BIOARC TO SLING SYSTEMS	Aug 11, 2004	Substantially Equivalent	American Medical Systems, Inc.
K041176	URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM	May 17, 2004	Substantially Equivalent	Sofradim Production
K040787	MODIFICATION TO SURGICAL MESH POLYMERIC	Apr 14, 2004	Substantially Equivalent	Boston Scientific
K040538	BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 72403996	Mar 17, 2004	Substantially Equivalent	American Medical Systems, Inc.
K033310	REMEEX SYSTEM FOR URINARY INCONTINENCE	Jan 15, 2004	Substantially Equivalent	Specialities Remeex International, S.L.
K033691	SAFYRE VS AND SAFYRE T	Dec 19, 2003	Substantially Equivalent	Promedon
K033568	GYNECARE TVT OBTURATOR SYSTEM	Dec 08, 2003	Substantially Equivalent	ETHICON, Inc.
K031767	MENTOR OBTAPE TRANS-OBTURATOR TAPE	Jul 17, 2003	Substantially Equivalent	Mentor Corp.
K030123	BIOARC SP SLING KIT	Feb 06, 2003	Substantially Equivalent	American Medical Systems, Inc.
K023516	MONARC SLING SYSTEM	Nov 19, 2002	Substantially Equivalent	American Medical Systems, Inc.
K021263	MODIFICATION TO SPARC SLING SYSTEM	May 15, 2002	Substantially Equivalent	American Medical Systems, Inc.
K020705	SIIS#1 TISSUE SUSPENSION SYSTEM	Apr 26, 2002	Substantially Equivalent	Tag Medical Products
K020110	MODIFICATION TO TRELEX MESH SURGICAL MESH	Apr 03, 2002	Substantially Equivalent	Boston Scientific
K020663	MODIFICATION TO SPARC SLING SYSTEM	Mar 28, 2002	Substantially Equivalent	American Medical Systems, Inc.
K020007	SAFYRE SLING SYSTEM	Mar 21, 2002	Substantially Equivalent	Promedon
K013355	SPARC SLING SYSTEM	Oct 26, 2001	Substantially Equivalent	American Medical Systems, Inc.
K012628	GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM	Oct 26, 2001	Substantially Equivalent	Gynecare Center
K012949	URETEX SUP PUBOURETHRAL SLING	Oct 04, 2001	Substantially Equivalent	Sofradim Production
K011251	SPARC SLING SYSTEM	Aug 01, 2001	Substantially Equivalent	American Medical Systems, Inc.
K982042	ISLAND BIOSURGICAL BLADDER NECK BOLSTR MODEL IBIBOL.002	Sep 08, 1998	Substantially Equivalent	Island Biosurgical, Inc.
K980482	TRIANGLE SLING	Mar 27, 1998	Substantially Equivalent	Influence, Inc.
K974098	PUBOUURETHRAL SLING	Jan 28, 1998	Substantially Equivalent	ETHICON, Inc.
K973022	ISLAND BIOSURGICAL INC. BNS KIT #1 & #2	Oct 20, 1997	Substantially Equivalent	Island Biosurgical, Inc.
K972651	IN-SLING	Sep 19, 1997	Substantially Equivalent	Influence, Inc.
K960101	ISLAND BIOSURGICAL BOLSTER	Dec 16, 1996	Substantially Equivalent	Island Biosurgical, Inc.