K243412 is an FDA 510(k) clearance for the ARCHIMEDES Biodegradable Pancreatic Stent. This device is classified as a Stents, Drains And Dilators For The Biliary Ducts (Class II - Special Controls, product code FGE).
Submitted by Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) (Charlotte, US). The FDA issued a Cleared decision on July 16, 2025, 257 days after receiving the submission on November 1, 2024.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K243412 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 2024 |
| Decision Date | July 16, 2025 |
| Days to Decision | 257 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FGE - Stents, Drains And Dilators For The Biliary Ducts |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5010 |