Data / Medical devices / United States / Ultratellege USA Co. LTD.
Ultratellege USA Co. LTD.: FDA-registered device maker in Erie, PA, United States, 3 510(k) clearances
Ultratellege USA Co. LTD. is registered with the FDA (registration 3009543101) in Erie, PA, United States. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated August 29, 2016. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3009543101
- Address
- 2111 Peninsula Drive, Erie, PA, United States, 16506
- Owner or operator
- Ultratellege USA Co. Ltd (10040377)
- Roles
- Manufacturer
- First device listed
- April 5, 2012
- Registered through
- 2026
- Brand names listed
- UreTron, UreTron Flexible Probe, UreTron Multi Probe Lithotripter System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lithotriptor, Electro-Hydraulic | FFK | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| August 29, 2016 | K162119 | UreTron PF Series Probe | FFK | Substantially Equivalent | Med-Sonics Corp. | accessdata.fda.gov |
| February 23, 2016 | K160198 | UreTron MultiProbe Lithotripter System | FFK | Substantially Equivalent | Med-Sonics Corp. | accessdata.fda.gov |
| March 30, 2012 | K111058 | URETRON MODEL URT | FFK | Substantially Equivalent | Med-Sonics Corp. | accessdata.fda.gov |
Compare with other makers
Updated August 29, 2016. 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.