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FDA 510(k)

EndoGI Biliary Stent System

K-Number: K193600 · 2020-06-26

Decision Date2020-06-26
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EndoGI Biliary Stent System is the device name listed in this FDA 510(k) record. The listed applicant is Endogi Medical, Ltd.. It received FDA 510(k) clearance on 2020-06-26 under 510(k) number K193600. 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 EndoGI Biliary Stent System?

EndoGI Biliary Stent System is a medical device that received FDA 510(k) clearance on 2020-06-26. The listed applicant is Endogi Medical, Ltd.. The 510(k) number is K193600.

When did EndoGI Biliary Stent System receive FDA 510(k) clearance?

EndoGI Biliary Stent System received FDA 510(k) clearance on 2020-06-26, under 510(k) number K193600.

Who is the listed applicant for EndoGI Biliary Stent System?

The FDA 510(k) record lists Endogi Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EndoGI Biliary Stent System?

The FDA product code for EndoGI Biliary Stent System is FGE.

Other records listing Endogi Medical, 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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