# Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)

- Location (FDA's records): Charlotte, NC
- FDA decisions: 2 (2025–2026): 2 510(k) clearances
- Product codes: FGE (2)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boston Scientific Corp: 2 (https://510kreport.com/company/boston-scientific)

## Its most-cited devices
- K243412: ARCHIMEDES Biodegradable Pancreatic Stent (2025), cited by 1

## Recent decisions
- K260835: ARCHIMEDES Biodegradable Stent (Medium) (Jul 27, 2026)
- K243412: ARCHIMEDES Biodegradable Pancreatic Stent (Jul 16, 2025)

Source page: https://510kreport.com/company/q3-medical-usa-c-o-q3-medical-devices