Data / Medical devices / United States / Q3 Medical Usa, LLC
Q3 Medical Usa, LLC: FDA-registered device maker in Charlotte, NC, United States, 2 510(k) clearances
Q3 Medical Usa, LLC is registered with the FDA (registration 3040505963) in Charlotte, NC, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated July 27, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3040505963
- Address
- 1800 Camden Rd Ste 107, Charlotte, NC, United States, 28203
- Owner or operator
- Q3 Medical USA, LLC (10094021)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 17, 2025
- Registered through
- 2026
- Brand names listed
- ARCHIMEDES Biodegradable Pancreatic Stent, ARCHIMEDES Biodegradable Stent
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stents, Drains And Dilators For The Biliary Ducts | FGE | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| July 27, 2026 | K260835 | ARCHIMEDES Biodegradable Stent (Medium) | FGE | Substantially Equivalent | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) | accessdata.fda.gov |
| July 16, 2025 | K243412 | ARCHIMEDES Biodegradable Pancreatic Stent | FGE | Substantially Equivalent | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) | accessdata.fda.gov |
Compare with other makers
Updated July 27, 2026. 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.