# K243412: ARCHIMEDES Biodegradable Pancreatic Stent

- Pathway: 510(k) (Traditional)
- Applicant: Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)
- Decided: Jul 16, 2025 after 257 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: 4 generations back to K834468 (1984). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133700: Advanix Pancreatic Stent and Naviflex Rapid Exchange Pancreatic Delivery System and Pushers, Boston Scientific Corporation (2014) Summary page 5.

## Most influential descendants
- K260835: ARCHIMEDES Biodegradable Stent (Medium) (2026), 0 descendants of its own

## Indications for use
The ARCHIMEDES biodegradable pancreatic stent is intended to drain pancreatic ducts in patients indicated for pancreatic duct stenting. The ARCHIMEDES Biodegradable Pancreatic Stent is intended to be delivered through the working channel of a therapeutic endoscope using a guidewire with a maximum outer diameter of 0.035 inches and a pushing catheter of between 5 to 10 French.

Source page: https://510kreport.com/device/K243412
Methodology: https://510kreport.com/methodology