Data / Medical devices / Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator (OTN): 20 FDA-registered makers in 7 countries
20 establishments in 7 countries are registered with the FDA to make Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator (product code OTN, Class 2, 21 CFR 878.3300). 11 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 66 510(k) clearances under this code, the latest on October 16, 2026, and lists 1 recall event (0 Class I). FDA data exported November 3, 2026.
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- Product code
- OTN
- Device class
- 2
- Regulation
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 12 |
| Switzerland | 3 |
| Ireland | 1 |
| Spain | 1 |
| France | 1 |
| Brazil | 1 |
| Costa Rica | 1 |
Makers of Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Caldera Medical, Inc. | Westlake Village, CA, United States | Manufacturer, Specification developer | 10 | November 10, 2021 | 0 | 0 | 0 | api.fda.gov |
| Caldera Medical Sarl | Neuchatel, Switzerland | Specification developer | 6 | September 17, 2020 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Marlborough, MA, United States | Specification developer | 4 | June 29, 2023 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Spencer, IN, United States | Manufacturer | 4 | June 29, 2023 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 4 | June 29, 2023 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Limited | GALWAY Galway(County), Ireland | Manufacturer | 4 | June 29, 2023 | 0 | 0 | 0 | api.fda.gov |
| Urocure, LLC | Norcross, GA, United States | Specification developer | 3 | September 21, 2022 | 0 | 0 | 0 | api.fda.gov |
| Coloplast Manufacturing Us, LLC | Minneapolis, MN, United States | Manufacturer, Specification developer | 2 | June 24, 2011 | 0 | 0 | 0 | api.fda.gov |
| Desarrollo E Investigacion Medica Aragonesa SL | CALATAYUD Zaragoza, Spain | Manufacturer | 2 | December 20, 2011 | 0 | 0 | 0 | api.fda.gov |
| APIS Technologies Sarl | Geneva Geneve, Switzerland | Manufacturer, Specification developer | 1 | August 11, 2005 | 0 | 0 | 0 | api.fda.gov |
| Athena Surgical | Minnetonka, MN, United States | Complaint file establishment, Specification developer | 1 | April 12, 2021 | 0 | 0 | 0 | api.fda.gov |
| Analytic Biosurgical Solutions (abiss) | Saint-Etienne Loire, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aprios Custom Mfg. | Minneapolis, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bard Shannon Limited | Humacao, PR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BIOMERICS Advanced Catheter | Brooklyn Park, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ethicon Sarl | Neuchatel, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fabinject Industria E Comercio Importacao E Exportacao Ltda | Taubate Sao Paulo, Brazil | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| I-Tek Medical, Inc. | White Bear Lake, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LISI MEDICAL Remmele | Coon Rapids, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Synergy Health AST, SRL | Alajuela, Costa Rica | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.