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FDA 510(k)

EndoGI S-Path Biliary Stent System

K-Number: K232596 · 2023-09-27

Decision Date2023-09-27
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

EndoGI S-Path 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 2023-09-27 under 510(k) number K232596. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the EndoGI S-Path Biliary Stent System?

EndoGI S-Path Biliary Stent System is a medical device that received FDA 510(k) clearance on 2023-09-27. The listed applicant is Endogi Medical, Ltd.. The 510(k) number is K232596.

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

EndoGI S-Path Biliary Stent System received FDA 510(k) clearance on 2023-09-27, under 510(k) number K232596.

Who is the listed applicant for EndoGI S-Path 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 S-Path Biliary Stent System?

The FDA product code for EndoGI S-Path 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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