Data / Medical devices / United States / Urethrotech Inc.
Urethrotech Inc.: FDA-registered device maker in Winston Salem, NC, United States, 1 510(k) clearance
Urethrotech Inc. is registered with the FDA (registration 3016998661) in Winston Salem, NC, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 4, 2019. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3016998661
- Address
- 111 N. Chestnut Street Suite 104, Winston Salem, NC, United States, 27101
- Owner or operator
- Urethrotech Inc. (10075263)
- Roles
- Complaint file establishment
- First device listed
- July 15, 2025
- Registered through
- 2026
- Brand names listed
- Urethral Catheterisation Device (UCD®)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Retention Type, Balloon | EZL | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| October 4, 2019 | K190060 | Urethrotech UCD | EZL | Substantially Equivalent | Urethrotech | accessdata.fda.gov |
Compare with other makers
Updated October 4, 2019. 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.