OTN — Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator Class II
Classification Details
- Product Code
- OTN
- Device Class
- Class II
- Regulation Number
- 878.3300
- Submission Type
- Review Panel
- GU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Definition
Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K231549 | boston scientific corporation | Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System | June 29, 2023 |
| K222293 | urocure | ArcSP Suprapubic Sling System | September 21, 2022 |
| K222468 | urocure | ArcTO Transobturator Sling System | September 15, 2022 |
| K211975 | caldera medical | Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, | November 10, 2021 |
| K211223 | boston scientific corporation | Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System | July 21, 2021 |
| K210087 | athena surgical | Athena Surgical RMUS System | April 12, 2021 |
| K201686 | ethicon | GYNECARE TVT System, GYNECARE TVT with Abdominal Guides System, GYNECARE TVT | September 17, 2020 |
| K183134 | urocure | ArcTV Transvaginal Sling System | February 7, 2019 |
| K162201 | caldera medical | Desara TV, Desara Blue TV | January 11, 2017 |
| K140843 | caldera medical | DESARA BLUE OV, DESARA BLUE SS | July 1, 2014 |
| K131229 | american medical systems | SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS | December 5, 2013 |
| K132655 | american medical systems | RETROARC RETROPUBIC SLING SYSTEM | November 20, 2013 |
| K132069 | caldera medical | DESARA MESH, DESARA BLUE | September 23, 2013 |
| K132054 | ethicon | GYNECARE TVT EXACT CONTINENCE SYSTEM | August 23, 2013 |
| K121928 | caldera medical | DESARA SL | February 19, 2013 |
| K121754 | boston scientific | BLUE SUI SLING | October 10, 2012 |
| K103022 | neomedic international s.l | KIM | December 20, 2011 |
| K112609 | caldera medical | DESARA MESH | September 30, 2011 |
| K111219 | generic medical device | GMD UNIVERSAL URINARY INCONTINENCE SLING | June 30, 2011 |
| K111233 | coloplast | SUPRIS RETROPUBIC SLING SYSTEM | June 24, 2011 |