Data / Medical devices / Mesh, Surgical, For Stress Urinary Incontinence, Male
Mesh, Surgical, For Stress Urinary Incontinence, Male (OTM): 7 FDA-registered makers in 3 countries
7 establishments in 3 countries are registered with the FDA to make Mesh, Surgical, For Stress Urinary Incontinence, Male (product code OTM, Class 2, 21 CFR 878.3300). 7 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 12 510(k) clearances under this code, the latest on November 15, 2024, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OTM
- Device class
- 2
- Regulation
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Switzerland | 1 |
| Spain | 1 |
Makers of Mesh, Surgical, For Stress Urinary Incontinence, Male
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 |
|---|---|---|---|---|---|---|---|---|
| Boston Scientific Corporation | Marlborough, MA, United States | Specification developer | 2 | December 20, 2021 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Spencer, IN, United States | Manufacturer, Manufacturer for export | 2 | December 20, 2021 | 0 | 0 | 0 | api.fda.gov |
| Coloplast Manufacturing Us, LLC | Minneapolis, MN, United States | Manufacturer | 2 | September 25, 2023 | 0 | 0 | 0 | api.fda.gov |
| APIS Technologies Sarl | Geneva Geneve, Switzerland | Manufacturer, Specification developer | 1 | November 7, 2006 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corp., Marina Bay Cust. Fulfillment Center | Quincy, MA, United States | Manufacturer | 1 | December 20, 2021 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 1 | December 20, 2021 | 0 | 0 | 0 | api.fda.gov |
| Desarrollo E Investigacion Medica Aragonesa SL | CALATAYUD Zaragoza, Spain | Manufacturer | 1 | November 2, 2006 | 0 | 0 | 0 | api.fda.gov |
Updated November 15, 2024. 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.