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FDA 510(k)

GORE VIABIL BILILARY ENDOPROSTHESIS

K-Number: K081184 · 2008-07-22

Decision Date2008-07-22
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

GORE VIABIL BILILARY ENDOPROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is W.L. Gore & Associates, Inc. Medical Products Div.. It received FDA 510(k) clearance on 2008-07-22 under 510(k) number K081184. 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 BILILARY ENDOPROSTHESIS?

GORE VIABIL BILILARY ENDOPROSTHESIS is a medical device that received FDA 510(k) clearance on 2008-07-22. The listed applicant is W.L. Gore & Associates, Inc. Medical Products Div.. The 510(k) number is K081184.

When did GORE VIABIL BILILARY ENDOPROSTHESIS receive FDA 510(k) clearance?

GORE VIABIL BILILARY ENDOPROSTHESIS received FDA 510(k) clearance on 2008-07-22, under 510(k) number K081184.

Who is the listed applicant for GORE VIABIL BILILARY ENDOPROSTHESIS?

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

What is the FDA product code for GORE VIABIL BILILARY ENDOPROSTHESIS?

The FDA product code for GORE VIABIL BILILARY 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.

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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