Clearance Summary
ARCHIMEDES Biodegradable Stent (Medium) received FDA 510(k) clearance under submission number K260835, sponsored by Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.). The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2026-07-27.
- Submission: K260835
- Applicant / Sponsor: Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5010
- Decision date: 2026-07-27
Classification & Regulation
This clearance is catalogued under FDA product code FGE and 21 CFR 876.5010, within the Gastroenterology, Urology review panel as a Class II device.