Data / Medical devices / United States / GT Medical Technologies
GT Medical Technologies: FDA-registered device maker in Richland, WA, United States, 4 510(k) clearances
GT Medical Technologies is registered with the FDA (registration 3005520039) in Richland, WA, United States. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated August 28, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005520039
- Address
- 350 Hills St Ste 106, Richland, WA, United States, 99354
- Owner or operator
- GT Medical Technologies, Inc (10058091)
- Roles
- Manufacturer
- First device listed
- April 18, 2024
- Registered through
- 2026
- Brand names listed
- CS-1, CS-1NS, PL-1, PL-2, PL-3, PL-4, PL-4NS, PL-5 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Source, Brachytherapy, Radionuclide | KXK | 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 28, 2009 | K092458 | PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2 | KXK | Substantially Equivalent | Isoray Medical, Inc. | accessdata.fda.gov |
| August 7, 2009 | K092136 | PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5 | KXK | Substantially Equivalent | Isoray Medical, Inc. | accessdata.fda.gov |
| November 9, 2006 | K062384 | CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE | KXK | Substantially Equivalent | Isoray, Inc. | accessdata.fda.gov |
| March 28, 2003 | K030162 | LAWRENCE CSERION, MODEL CS-1 | KXK | Substantially Equivalent | Isoray, Inc. | accessdata.fda.gov |
Compare with other makers
Updated August 28, 2009. 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.