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FDA 510(k)

ARCHSTENT BILIARY SYSTEM

K-Number: K113582 · 2012-06-29

Decision Date2012-06-29
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

ARCHSTENT BILIARY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ostial Corporation. It received FDA 510(k) clearance on 2012-06-29 under 510(k) number K113582. 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 ARCHSTENT BILIARY SYSTEM?

ARCHSTENT BILIARY SYSTEM is a medical device that received FDA 510(k) clearance on 2012-06-29. The listed applicant is Ostial Corporation. The 510(k) number is K113582.

When did ARCHSTENT BILIARY SYSTEM receive FDA 510(k) clearance?

ARCHSTENT BILIARY SYSTEM received FDA 510(k) clearance on 2012-06-29, under 510(k) number K113582.

Who is the listed applicant for ARCHSTENT BILIARY SYSTEM?

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

What is the FDA product code for ARCHSTENT BILIARY SYSTEM?

The FDA product code for ARCHSTENT BILIARY SYSTEM 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 Ostial Corporation 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 10 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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