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FDA 510(k)

GORE VIABIL Short Wire Biliary Endoprosthesis

K-Number: K170740 · 2017-05-08

Decision Date2017-05-08
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

GORE VIABIL Short Wire Biliary Endoprosthesis is the device name listed in this FDA 510(k) record. The listed applicant is W. L. Gore & Associates, Inc.. It received FDA 510(k) clearance on 2017-05-08 under 510(k) number K170740. 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 GORE VIABIL Short Wire Biliary Endoprosthesis?

GORE VIABIL Short Wire Biliary Endoprosthesis is a medical device that received FDA 510(k) clearance on 2017-05-08. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K170740.

When did GORE VIABIL Short Wire Biliary Endoprosthesis receive FDA 510(k) clearance?

GORE VIABIL Short Wire Biliary Endoprosthesis received FDA 510(k) clearance on 2017-05-08, under 510(k) number K170740.

Who is the listed applicant for GORE VIABIL Short Wire Biliary Endoprosthesis?

The FDA 510(k) record lists W. L. Gore & Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GORE VIABIL Short Wire Biliary Endoprosthesis?

The FDA product code for GORE VIABIL Short Wire Biliary Endoprosthesis 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 W. L. Gore & Associates, 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.

View all 24 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

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