Data / Medical devices / United States / URGO Medical North America, LLC
URGO Medical North America, LLC: FDA-registered device maker in Fort Worth, TX, United States, 3 510(k) clearances
URGO Medical North America, LLC is registered with the FDA (registration 3010060216) in Fort Worth, TX, United States. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated May 14, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010060216
- Address
- 100 Lexington Street, Suite 400, Fort Worth, TX, United States, 76102
- Owner or operator
- URGO Medical North America LLC (10042824)
- Roles
- Manufacturer, Specification developer
- First device listed
- May 31, 2016
- Registered through
- 2026
- Brand names listed
- Vashe Gel, Vashe Wound Solution, Vashe Wound Solution OTC
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 14, 2015 | K141863 | PURICORE WOUND HYDROGEL SPRAY DRESSING | FRO | Substantially Equivalent | Puricore, Inc. | accessdata.fda.gov |
| March 31, 2014 | K131848 | VASHE WOUND SOLUTION (4.0 OZ), (8.5 OZ & (16.0 OZ) | FRO | Substantially Equivalent | Puricore, Inc. | accessdata.fda.gov |
| April 13, 2010 | K093697 | VASHE WOUND THERAPY SOLUTION | FRO | Substantially Equivalent | Puricore, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 14, 2015. 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.