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FDA 510(k)

ARCHIMEDES Biodegradable Pancreatic Stent

K-Number: K243412 · 2025-07-16

ApplicantQ3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)
Decision Date2025-07-16
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ARCHIMEDES Biodegradable Pancreatic Stent is a medical device manufactured by Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.). It received FDA 510(k) clearance on 2025-07-16 under approval number K243412. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARCHIMEDES Biodegradable Pancreatic Stent?

ARCHIMEDES Biodegradable Pancreatic Stent is a medical device that received FDA 510(k) clearance on 2025-07-16. It is manufactured by Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.). The 510(k) number is K243412.

When was ARCHIMEDES Biodegradable Pancreatic Stent approved by the FDA?

ARCHIMEDES Biodegradable Pancreatic Stent received FDA 510(k) clearance on 2025-07-16, under approval number K243412.

What company makes ARCHIMEDES Biodegradable Pancreatic Stent?

ARCHIMEDES Biodegradable Pancreatic Stent is manufactured by Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.).

What is the FDA product code for ARCHIMEDES Biodegradable Pancreatic Stent?

The FDA product code for ARCHIMEDES Biodegradable Pancreatic Stent is FGE.

Related Clinical Trials

NCT07607353 Biodegradable Stents in Primary Sclerosing Cholangitis RECRUITING NCT07606430 Comparison of a Short Modified Metal Stent Versus Plastic Stent as a Bridge to Surgery in Pancreatic Cancer With Malignant Biliary Obstruction NOT_YET_RECRUITING NCT07495111 Prophylactic PS Placement to Prevent Pancreatitis After Endoscopic Transpapillary GPC for Cholelithiasis With Concomitant Choledocholithiasis RECRUITING NCT05650411 Ultrathin-strut Biodegradable Polymer Sirolimus-eluting Stents With P2Y12 Inhibitor-based Single Antiplatelet Therapy vs. Conventional DAPT for Unprotected Left Main Coronary Artery Disease (ULTIMATE-LM) RECRUITING NCT06719089 Evaluation of the Safety and Performance of the Hydrustent® Biodegradable Hydrogel Ureteral Stent RECRUITING NCT06663696 CRUZ Tunisia-Multivessel Registry RECRUITING

Related Devices (Code: FGE)

K163018Zilver 635 Biliary StentCook Ireland, Ltd. K162404Express SD Biliary Monorail Premounted Stent SystemBoston Scientific Corporation K161203Soehendra Stent RetrieverWilson-Cook Medical, Inc. K150487X-Suit NIR Biliary Metallic StentMedinol, Ltd. K171548Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation CatheterWilson-Cook Medical, Inc. K172520CRE RX Biliary Balloon Dilatation CatheterBoston Scientific Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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