K243412 is an FDA 510(k) clearance for the ARCHIMEDES Biodegradable Pancreatic Stent. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.
Submitted by Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) (Charlotte, US). The FDA issued a Cleared decision on July 16, 2025 after a review of 257 days - an extended review cycle.
This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.
View all Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) devices
NCT03767166
Completed
Observational
The Archimedes Biodegradable Biliary and Pancreatic Stents
A Prospective, Single Arm Study to Evaluate the Feasibility of the Archimedes Biodegradable Biliary and Pancreatic Stents Placement
| Condition studied |
Pancreatic Diseases |
| Eligibility |
All sexes
· 18 Years+
|
| Sponsor |
Istituto Clinico Humanitas
|
Started 2019-02-01
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Primary completion 2020-12-31
Primary outcome
Biodegradation time
Study completed - no results published.
This trial concluded in 2020 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
Individual participant data will not be shared.
View full study on ClinicalTrials.gov