# K260835: ARCHIMEDES Biodegradable Stent (Medium)

- Pathway: 510(k) (Traditional)
- Applicant: Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)
- Decided: Jul 27, 2026 after 136 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K834468 (1984). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243412: ARCHIMEDES Biodegradable Pancreatic Stent, Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) (2025) Summary page 5.
- K203162: Advanix Biliary Stent with NaviFlex RX Delivery System, Boston Scientific Corporation (2020) Summary page 6.

## Indications for use
The ARCHIMEDES Biodegradable Stent (Medium) is intended to drain biliary ducts in patients indicated for biliary duct stenting. The ARCHIMEDES Biodegradable Stent (Medium) is intended to drain pancreatic ducts in patients indicated for pancreatic duct stenting.

Source page: https://510kreport.com/device/K260835
Methodology: https://510kreport.com/methodology