OTN — Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator Class II
FDA product code OTN covers "Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator", a Class II medical device regulated under 21 CFR 878.3300. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
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 |