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FDA 510(k)

GORE BIO-A FISTULA PLUG

K-Number: K083266 · 2009-03-27

ApplicantW. L. Gore & Associates, Inc.
Decision Date2009-03-27
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GORE BIO-A FISTULA PLUG 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 2009-03-27 under 510(k) number K083266. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GORE BIO-A FISTULA PLUG?

GORE BIO-A FISTULA PLUG is a medical device that received FDA 510(k) clearance on 2009-03-27. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K083266.

When did GORE BIO-A FISTULA PLUG receive FDA 510(k) clearance?

GORE BIO-A FISTULA PLUG received FDA 510(k) clearance on 2009-03-27, under 510(k) number K083266.

Who is the listed applicant for GORE BIO-A FISTULA PLUG?

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 BIO-A FISTULA PLUG?

The FDA product code for GORE BIO-A FISTULA PLUG is FTL.

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Other records listing W. L. Gore & Associates, Inc. as applicant

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K250410GORE® Tri-Lobe Balloon CatheterK240083GORE® PROPATEN® Vascular GraftK232312GORE® PROPATEN® Vascular GraftK233551GORE® ACUSEAL Vascular GraftK231505GORE® ACUSEAL Vascular GraftK222919GORE® ENFORM Biomaterial

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Related Devices (Code: FTL)

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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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