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FDA 510(k)

AngioDynamics Total Abscession Biliary Drainage Catheter

K-Number: K170743 · 2017-03-30

Decision Date2017-03-30
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AngioDynamics Total Abscession Biliary Drainage Catheter is the device name listed in this FDA 510(k) record. The listed applicant is AngioDynamics, Inc.. It received FDA 510(k) clearance on 2017-03-30 under 510(k) number K170743. 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 AngioDynamics Total Abscession Biliary Drainage Catheter?

AngioDynamics Total Abscession Biliary Drainage Catheter is a medical device that received FDA 510(k) clearance on 2017-03-30. The listed applicant is AngioDynamics, Inc.. The 510(k) number is K170743.

When did AngioDynamics Total Abscession Biliary Drainage Catheter receive FDA 510(k) clearance?

AngioDynamics Total Abscession Biliary Drainage Catheter received FDA 510(k) clearance on 2017-03-30, under 510(k) number K170743.

Who is the listed applicant for AngioDynamics Total Abscession Biliary Drainage Catheter?

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

What is the FDA product code for AngioDynamics Total Abscession Biliary Drainage Catheter?

The FDA product code for AngioDynamics Total Abscession Biliary Drainage Catheter 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 AngioDynamics, Inc. 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.

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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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.