OTN · Class II · 21 CFR 878.3300

FDA Product Code OTN: Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

FDA product code OTN covers synthetic urogynecological mesh used for the surgical treatment of female stress urinary incontinence.

These synthetic polypropylene mesh tapes are placed under the mid-urethra through a minimally invasive approach to provide a supportive hammock that prevents urinary leakage during physical activity. Midurethral slings have become the standard surgical treatment for stress urinary incontinence.

OTN devices are Class II medical devices, regulated under 21 CFR 878.3300 and reviewed by the FDA Gastroenterology & Urology panel.

Leading manufacturers include American Medical Systems, Inc., Caldera Medical, Inc. and Ethicon, Inc..

66
Total
66
Cleared
83d
Avg days
1996
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg 102d recently vs 82d historically

FDA 510(k) Cleared Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator Devices (Product Code OTN)

66 devices
1–24 of 66
Cleared Oct 16, 2026
KIM BLUE
K262284
Desarrollo e Investigación Médica Aragonesa S.L.
Gastroenterology & Urology · 102d
Cleared Jun 29, 2023
Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
K231549
Boston Scientific Corporation
Gastroenterology & Urology · 30d
Cleared Sep 21, 2022
ArcSP Suprapubic Sling System
K222293
Urocure, LLC
Gastroenterology & Urology · 51d
Cleared Sep 15, 2022
ArcTO Transobturator Sling System
K222468
Urocure, LLC
Gastroenterology & Urology · 30d
Cleared Nov 10, 2021
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.
Gastroenterology & Urology · 138d
Cleared Jul 21, 2021
Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
K211223
Boston Scientific Corporation
Gastroenterology & Urology · 89d
Cleared Apr 12, 2021
Athena Surgical RMUS System
K210087
Athena Surgical, LLC
Gastroenterology & Urology · 89d
Cleared Sep 17, 2020
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.
Gastroenterology & Urology · 87d
Cleared Feb 07, 2019
ArcTV Transvaginal Sling System
K183134
Urocure, LLC
Gastroenterology & Urology · 86d
Cleared Jan 11, 2017
Desara TV, Desara Blue TV
K162201
Caldera Medical, Inc.
Gastroenterology & Urology · 159d
Cleared Jul 01, 2014
DESARA BLUE OV, DESARA BLUE SS
K140843
Caldera Medical
Gastroenterology & Urology · 90d
Cleared Dec 05, 2013
SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS
K131229
American Medical Systems
Gastroenterology & Urology · 219d
Cleared Nov 20, 2013
RETROARC RETROPUBIC SLING SYSTEM
K132655
American Medical Systems, Inc.
Gastroenterology & Urology · 86d
Cleared Sep 23, 2013
DESARA MESH, DESARA BLUE
K132069
Caldera Medical, Inc.
Gastroenterology & Urology · 82d
Cleared Aug 23, 2013
GYNECARE TVT EXACT CONTINENCE SYSTEM
K132054
Ethicon, Inc.
Gastroenterology & Urology · 51d
Cleared Feb 19, 2013
DESARA SL
K121928
Caldera Medical, Inc.
Gastroenterology & Urology · 232d
Cleared Oct 10, 2012
BLUE SUI SLING
K121754
Boston Scientific Corp
Gastroenterology & Urology · 118d
Cleared Dec 20, 2011
KIM
K103022
Neomedic International S.L.
Gastroenterology & Urology · 434d
Cleared Sep 30, 2011
DESARA MESH
K112609
Caldera Medical, Inc.
Gastroenterology & Urology · 22d
Cleared Jun 30, 2011
GMD UNIVERSAL URINARY INCONTINENCE SLING
K111219
Generic Medical Device, Inc.
Gastroenterology & Urology · 59d
Cleared Jun 24, 2011
SUPRIS RETROPUBIC SLING SYSTEM
K111233
Coloplast A/S
Gastroenterology & Urology · 53d
Cleared Jul 01, 2010
GYNECARE TVT ABBREVO CONTINENCE SYSTEM
K100936
Ethicon, Inc.
Gastroenterology & Urology · 87d
Cleared Jun 18, 2010
GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012
K101440
Generic Medical Devices, Inc.
Gastroenterology & Urology · 25d
Cleared May 20, 2010
DESARA MESH MODEL: CAL-DS01
K101169
Caldera Medical, Inc.
Gastroenterology & Urology · 24d

About Product Code OTN - Regulatory Context

510(k) Submission Activity

66 total 510(k) submissions under product code OTN since 1996, with 66 receiving FDA clearance (average review time: 83 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - OTN Product Code

Recent submissions under OTN have taken an average of 102 days to reach a decision - up from 82 days historically. Manufacturers should account for longer review timelines in current project planning.

OTN devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →