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FDA 510(k)

ARCHIMEDES Biodegradable Pancreatic Stent

K-Number: K243412 · 2025-07-16

Decision Date2025-07-16
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ARCHIMEDES Biodegradable Pancreatic Stent is the device name listed in this FDA 510(k) record. The listed applicant is Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.). It received FDA 510(k) clearance on 2025-07-16 under 510(k) 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. The listed applicant is Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.). The 510(k) number is K243412.

When did ARCHIMEDES Biodegradable Pancreatic Stent receive FDA 510(k) clearance?

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

Who is the listed applicant for ARCHIMEDES Biodegradable Pancreatic Stent?

The FDA 510(k) record lists Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: FGE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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