OTN · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
General, Plastic Surgery · 21 CFR 878.3300 · Class 2
Overview
| Product Code | OTN |
|---|---|
| Device Name | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Regulation | 21 CFR 878.3300 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
Identification
Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 65)
Showing 20 most recent of 65 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K231549 | Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System | Boston Scientific Corporation | Jun 29, 2023 | SESE |
| K222293 | ArcSP Suprapubic Sling System | Urocure, LLC | Sep 21, 2022 | SESE |
| K222468 | ArcTO Transobturator Sling System | Urocure, LLC | Sep 15, 2022 | SESE |
| 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. | Nov 10, 2021 | SESE |
| K211223 | Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System | Boston Scientific Corporation | Jul 21, 2021 | SESE |
| K210087 | Athena Surgical RMUS System | Athena Surgical, LLC | Apr 12, 2021 | SESE |
| 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 | ETHICON, Inc. | Sep 17, 2020 | SESE |
| K183134 | ArcTV Transvaginal Sling System | Urocure, LLC | Feb 7, 2019 | SESE |
| K162201 | Desara TV, Desara Blue TV | Caldera Medical, Inc. | Jan 11, 2017 | SESE |
| K140843 | DESARA BLUE OV, DESARA BLUE SS | Caldera Medical | Jul 1, 2014 | SESE |
| K131229 | SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS | American Medical Systems | Dec 5, 2013 | SESE |
| K132655 | RETROARC RETROPUBIC SLING SYSTEM | American Medical Systems, Inc. | Nov 20, 2013 | SESE |
| K132069 | DESARA MESH, DESARA BLUE | Caldera Medical, Inc. | Sep 23, 2013 | SESE |
| K132054 | GYNECARE TVT EXACT CONTINENCE SYSTEM | ETHICON, Inc. | Aug 23, 2013 | SESE |
| K121928 | DESARA SL | Caldera Medical, Inc. | Feb 19, 2013 | SESE |
| K121754 | BLUE SUI SLING | Boston Scientific Corp | Oct 10, 2012 | SESE |
| K103022 | KIM | Neomedic International S.L. | Dec 20, 2011 | SESE |
| K112609 | DESARA MESH | Caldera Medical, Inc. | Sep 30, 2011 | SESE |
| K111219 | GMD UNIVERSAL URINARY INCONTINENCE SLING | Generic Medical Device, Inc. | Jun 30, 2011 | SESE |
| K111233 | SUPRIS RETROPUBIC SLING SYSTEM | Coloplast A/S | Jun 24, 2011 | SESE |
Top Applicants
- American Medical Systems, Inc. — 13 clearances
- Caldera Medical, Inc. — 7 clearances
- ETHICON, Inc. — 6 clearances
- Urocure, LLC — 3 clearances
- Island Biosurgical, Inc. — 3 clearances
