ARCHIMEDES Biodegradable Stent (Medium)— 510(k) K260835
Substantially EquivalentQ3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)
FDA 510(k) clearance K260835 for ARCHIMEDES Biodegradable Stent (Medium), Substantially Equivalent on 2026-07-27. Applicant: Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.). Device class: 2.
Summary
Q3 Medical USA's ARCHIMEDES Biodegradable Stent (Medium) is filed under FGE, stents, drains, and dilators for the biliary ducts. The name says biodegradable and gives the size as Medium; the record doesn't give dimensions or materials.
Class II, 21 CFR 876.5010. Gastroenterology and Urology is both the classification panel and the review panel. It was a Traditional 510(k).
Q3 Medical USA filed from Charlotte, North Carolina, care of Q3 Medical Devices. Review took 136 calendar days (March 13 to July 27, 2026).
Clearance details
- Applicant
- Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)
- Product code
- Product code FGE
- Device class
- Class 2
- Regulation
- 21 CFR 876.5010
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Charlotte, NC, US
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- K253393 — Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019
- K253832 — Dilation Balloon Catheter
- K251658 — Endoflux Biliary & Pancreatic Stent Sets
More clearances from Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)
view allAdverse events under product code FGE
product code FGE- Death
- 52
- Injury
- 2,347
- Malfunction
- 9,798
- Other
- 1
- Total
- 12,198
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.