Product code OTN
- Device name
- Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.3300
- Review panel
- GU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231549 | Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System | Boston Scientific Corporation | 2023-06-29 |
| K222293 | ArcSP Suprapubic Sling System | Urocure, LLC | 2022-09-21 |
| K222468 | ArcTO Transobturator Sling System | Urocure, LLC | 2022-09-15 |
| 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. | 2021-11-10 |
| K211223 | Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System | Boston Scientific Corporation | 2021-07-21 |
| K210087 | Athena Surgical RMUS System | Athena Surgical, LLC | 2021-04-12 |
| 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 AB... | ETHICON, Inc. | 2020-09-17 |
| K183134 | ArcTV Transvaginal Sling System | Urocure, LLC | 2019-02-07 |
| K162201 | Desara TV, Desara Blue TV | Caldera Medical, Inc. | 2017-01-11 |
| K140843 | DESARA BLUE OV, DESARA BLUE SS | Caldera Medical | 2014-07-01 |
| K131229 | SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS | American Medical Systems | 2013-12-05 |
| K132655 | RETROARC RETROPUBIC SLING SYSTEM | American Medical Systems, Inc. | 2013-11-20 |
| K132069 | DESARA MESH, DESARA BLUE | Caldera Medical, Inc. | 2013-09-23 |
| K132054 | GYNECARE TVT EXACT CONTINENCE SYSTEM | ETHICON, Inc. | 2013-08-23 |
| K121928 | DESARA SL | Caldera Medical, Inc. | 2013-02-19 |
| K121754 | BLUE SUI SLING | Boston Scientific Corp | 2012-10-10 |
| K103022 | KIM | Neomedic International S.L. | 2011-12-20 |
| K112609 | DESARA MESH | Caldera Medical, Inc. | 2011-09-30 |
| K111219 | GMD UNIVERSAL URINARY INCONTINENCE SLING | Generic Medical Device, Inc. | 2011-06-30 |
| K111233 | SUPRIS RETROPUBIC SLING SYSTEM | Coloplast A/S | 2011-06-24 |
| K100936 | GYNECARE TVT ABBREVO CONTINENCE SYSTEM | ETHICON, Inc. | 2010-07-01 |
| K101440 | GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012 | Generic Medical Devices, Inc. | 2010-06-18 |
| K101169 | DESARA MESH MODEL: CAL-DS01 | Caldera Medical, Inc. | 2010-05-20 |
| K093747 | ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS | C.R. Bard, Inc. | 2010-05-07 |
| K100485 | GYNECARE TVT EXACT CONTINENCE SYSTEM | ETHICON, Inc. | 2010-03-16 |
| K092203 | OMNISURE URETHRAL SLING, MODEL OTK52 | Mpathy Medical Devices, Ltd. | 2009-08-12 |
| K083471 | GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020 | Generic Medical Device, Inc. | 2009-03-03 |
| K081613 | SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS | American Medical Systems, Inc. | 2008-09-17 |
| K072456 | DESARA MESH SLING, MODEL CAL-DS01 | Caldera Medical, Inc. | 2008-05-08 |
| K073647 | MINITAPE EXTRA URETHRAL SLING | Mpathy Medical Devices, Ltd. | 2008-03-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00890594000193 | Desara Blue TVez 2.7 | Caldera Medical, Inc. | 2022-08-03 |
| 00890594000155 | Desara TVez 3.0 | Caldera Medical, Inc. | 2022-08-03 |
| 00890594000131 | Desara TVez 2.7 | Caldera Medical, Inc. | 2022-08-03 |
| 00890594000124 | Desara Blue TVez 3.0 | Caldera Medical, Inc. | 2022-08-03 |
| 00890594000117 | Desara TVez 3.0 | Caldera Medical, Inc. | 2021-11-15 |
| 00890594000100 | Desara TVez 2.7 | Caldera Medical, Inc. | 2021-11-15 |
| 00890594000094 | Desara Blue TVez 2.7 | Caldera Medical, Inc. | 2021-11-15 |
| 00890594000087 | Desara Blue TVez 3.0 | Caldera Medical, Inc. | 2021-11-15 |
| 00191506007676 | Lynx Ultra System | BOSTON SCIENTIFIC CORPORATION | 2021-10-06 |
| 00191506007669 | Advantage Fit Ultra System | BOSTON SCIENTIFIC CORPORATION | 2021-10-06 |
| 00191506007652 | Advantage Ultra System | BOSTON SCIENTIFIC CORPORATION | 2021-10-06 |
| 00860003619827 | Athena Surgical RMUS System | Athena Surgical LLC | 2021-07-30 |
| 20860003619814 | Athena Surgical RMUS System | Athena Surgical LLC | 2021-07-30 |
| 00860003619803 | Athena Surgical RMUS System | Athena Surgical LLC | 2021-07-30 |
| 00860003619810 | Athena Surgical RMUS System | Athena Surgical LLC | 2021-07-30 |
| 00890594000902 | Desara TV | Caldera Medical, Inc. | 2019-09-30 |
| 00890594000896 | Desara | Caldera Medical, Inc. | 2019-09-30 |
| 00890594000858 | Desara Blue TV | Caldera Medical, Inc. | 2019-09-30 |
| 00890594000827 | Desara TV | Caldera Medical, Inc. | 2017-01-16 |
| 08714729856030 | Conservia™ | BOSTON SCIENTIFIC CORPORATION | 2015-11-23 |
| 08714729856016 | Conservia™ | BOSTON SCIENTIFIC CORPORATION | 2015-11-05 |
| 08714729855996 | Conservia™ | BOSTON SCIENTIFIC CORPORATION | 2015-11-05 |
| 00890594000629 | Desara | Caldera Medical, Inc. | 2015-10-30 |
| 08714729470274 | Advantage™ System | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729839255 | Obtryx™ II System - Curved | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729837565 | Obtryx™ II System - Halo | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729772880 | Advantage Fit™ System | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729718987 | Obtryx™ System - Halo | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729718963 | Obtryx™ System - Curved | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729718949 | Lynx™ System | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |