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FDA 510(k)

GI SUPPLY BILIARY STENT

K-Number: K031360 · 2003-09-24

ApplicantGi Supply
Decision Date2003-09-24
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GI SUPPLY BILIARY STENT is the device name listed in this FDA 510(k) record. The listed applicant is Gi Supply. It received FDA 510(k) clearance on 2003-09-24 under 510(k) number K031360. 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 GI SUPPLY BILIARY STENT?

GI SUPPLY BILIARY STENT is a medical device that received FDA 510(k) clearance on 2003-09-24. The listed applicant is Gi Supply. The 510(k) number is K031360.

When did GI SUPPLY BILIARY STENT receive FDA 510(k) clearance?

GI SUPPLY BILIARY STENT received FDA 510(k) clearance on 2003-09-24, under 510(k) number K031360.

Who is the listed applicant for GI SUPPLY BILIARY STENT?

The FDA 510(k) record lists Gi Supply as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GI SUPPLY BILIARY STENT?

The FDA product code for GI SUPPLY BILIARY 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 Gi Supply 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.

View all 8 devices →

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

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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