OTNFDA Class 2 · 21 CFR 878.3300 · implantable
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Device family · General, Plastic Surgery
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
65
Manufacturers
11
Flagged signals
20
Adverse-event reports
38,016
Code matrix
| FDA product code | OTN |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3300 |
| GMDN | — (crosswalk pending) |
| Implantable | Yes |
| Life-sustaining | No |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Death | 2016 | 29 | 18.8 | 476 |
| Death | 2015 | 74 | 11.3 | 693 |
| Death | 2007 | 10 | 6.5 | 41 |
| Death | 2009 | 9 | 5.8 | 32 |
| Death | 2011 | 9 | 5.8 | 32 |
| Death | 2013 | 8 | 5.2 | 23 |
| Death | 2014 | 30 | 4.6 | 82 |
| Death | 2006 | 7 | 4.5 | 16 |
| Death | 2008 | 6 | 3.9 | 10 |
| Death | 2014 | 5 | 3.2 | 6 |
| Death | 2011 | 19 | 2.9 | 22 |
| Injury | 2021 | 5 | 2.6 | 6 |
| Injury | 2013 | 373 | 2.5 | 558 |
| Injury | 2013 | 590 | 2.5 | 880 |
| Injury | 2013 | 29 | 2.5 | 41 |
| Death | 2010 | 16 | 2.5 | 12 |
| Injury | 2013 | 92 | 2.4 | 114 |
| Injury | 2013 | 50 | 2.2 | 52 |
| Death | 2016 | 14 | 2.1 | 8 |
| Death | 2012 | 14 | 2.1 | 8 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 38,016 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| AMERICAN MEDICAL SYSTEMS, INC. | 13 | 2013 | — |
| Caldera Medical, Inc. | 7 | 2021 | — |
| Ethicon, Inc. | 6 | 2020 | — |
| Mentor Corp. | 2 | 2004 | — |
| SOFRADIM PRODUCTION | 2 | 2004 | — |
| C.R. Bard, Inc. | 2 | 2010 | — |
| Boston Scientific | 2 | 2004 | — |
| BOSTON SCIENTIFIC CORPORATION | 2 | 2023 | 0.14 |
| Coloplast A/S | 1 | 2011 | — |
| Uroplasty, Inc. | 1 | 2005 | — |
| Boston Scientific Corp | 1 | 2012 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System · Boston Scientific Corporation510(k) · 2023-06-29
ArcSP Suprapubic Sling System · Urocure, LLC510(k) · 2022-09-21
ArcTO Transobturator Sling System · Urocure, LLC510(k) · 2022-09-15
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.510(k) · 2021-11-10
Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System · Boston Scientific Corporation510(k) · 2021-07-21
Athena Surgical RMUS System · Athena Surgical, LLC510(k) · 2021-04-12
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.510(k) · 2020-09-17
ArcTV Transvaginal Sling System · Urocure, LLC510(k) · 2019-02-07
Desara TV, Desara Blue TV · Caldera Medical, Inc.510(k) · 2017-01-11
DESARA BLUE OV, DESARA BLUE SS · Caldera Medical510(k) · 2014-07-01
SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS · American Medical Systems510(k) · 2013-12-05
RETROARC RETROPUBIC SLING SYSTEM · American Medical Systems, Inc.510(k) · 2013-11-20
DESARA MESH, DESARA BLUE · Caldera Medical, Inc.510(k) · 2013-09-23
GYNECARE TVT EXACT CONTINENCE SYSTEM · ETHICON, Inc.510(k) · 2013-08-23
DESARA SL · Caldera Medical, Inc.510(k) · 2013-02-19
BLUE SUI SLING · Boston Scientific Corp510(k) · 2012-10-10
KIM · Neomedic International S.L.510(k) · 2011-12-20
DESARA MESH · Caldera Medical, Inc.510(k) · 2011-09-30
GMD UNIVERSAL URINARY INCONTINENCE SLING · Generic Medical Device, Inc.510(k) · 2011-06-30
SUPRIS RETROPUBIC SLING SYSTEM · Coloplast A/S510(k) · 2011-06-24
GYNECARE TVT ABBREVO CONTINENCE SYSTEM · ETHICON, Inc.510(k) · 2010-07-01
GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012 · Generic Medical Devices, Inc.510(k) · 2010-06-18
DESARA MESH MODEL: CAL-DS01 · Caldera Medical, Inc.510(k) · 2010-05-20
ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS · C.R. Bard, Inc.510(k) · 2010-05-07
GYNECARE TVT EXACT CONTINENCE SYSTEM · ETHICON, Inc.510(k) · 2010-03-16
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.