K243412
- 510(k) number
- K243412
- Device name
- ARCHIMEDES Biodegradable Pancreatic Stent
- Applicant
- Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) NC · US
- Product code
- FGE — Stents, Drains And Dilators For The Biliary Ducts
- Decision date
- 2025-07-16
- Date received
- 2024-11-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K243412.pdf
Official FDA record: K243412
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.