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Gi Supply Biliary Stent

FDA 510(k)

Class II (US FDA 510(k))

510(k) K031360

by Gi Supply

Identifiers

510(k) Number
K031360 FDA 510(k)
FDA Product Code
FGE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5010 FDA 510(k)
Regulation Number
876.5010 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Gi Supply Biliary Stent is a stent designed for endoscopic placement to bypass biliary tree obstructions, facilitating bile drainage into the duodenum. It functions as a conduit for fluid. The device is classified as a Stent, Drain And Dilator For The Biliary Ducts, and is used in the medical specialty of Gastroenterology and Urology.

The Gi Supply Biliary Stent is a single-use, disposable medical device. It is supplied for use in clinical or hospital settings during endoscopic procedures, and is used by gastroenterologists or interventional radiologists. The device has the product code FGE and is regulated under 876.5010. It was found to be Substantially Equivalent and has the FDA 510(k) number K031360.

Frequently asked questions

What is the Gi Supply Biliary Stent used for?

The Gi Supply Biliary Stent is used to bypass biliary tree obstructions, facilitating bile drainage into the duodenum, in clinical or hospital settings during endoscopic procedures.

Is the Gi Supply Biliary Stent reusable?

No, the Gi Supply Biliary Stent is a single-use, disposable medical device.

What medical specialty uses the Gi Supply Biliary Stent?

The Gi Supply Biliary Stent is used in the medical specialties of Gastroenterology and Urology.

How is the Gi Supply Biliary Stent supplied?

The Gi Supply Biliary Stent is supplied for use in clinical or hospital settings during endoscopic procedures, and is used by gastroenterologists or interventional radiologists.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: GI SUPPLY BILIARY STENT (K031360) — FDA 510(k) | Innolitics, GI SUPPLY BILIARY STENT 510 (k) K031360 - FDA.report, Stents: Gastrointestinal - Boston Scientific

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Gi Supply

Sources (1)

  • FDA 510(k) K031360 24 fields · synced Sep 22, 2026