K260835
- 510(k) number
- K260835
- Device name
- ARCHIMEDES Biodegradable Stent (Medium)
- 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
- 2026-07-27
- Date received
- 2026-03-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K260835.pdf
Official FDA record: K260835
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.