FDA 510(k)

GORE-TEX SOFT TISSUE PATCH PLUS/DUALMESH PLUS BIOMATERIAL/MYCROMESH PLUS BIOMATERIAL/DUALMESH PLUS BIOMATERIAL WITH HOLE

K-Number: K965038 · 1997-02-06

Decision Date1997-02-06

Product CodeFTL

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

GORE-TEX SOFT TISSUE PATCH PLUS/DUALMESH PLUS BIOMATERIAL/MYCROMESH PLUS BIOMATERIAL/DUALMESH PLUS BIOMATERIAL WITH HOLE 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 1997-02-06 under 510(k) number K965038. 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-TEX SOFT TISSUE PATCH PLUS/DUALMESH PLUS BIOMATERIAL/MYCROMESH PLUS BIOMATERIAL/DUALMESH PLUS BIOMATERIAL WITH HOLE?

GORE-TEX SOFT TISSUE PATCH PLUS/DUALMESH PLUS BIOMATERIAL/MYCROMESH PLUS BIOMATERIAL/DUALMESH PLUS BIOMATERIAL WITH HOLE is a medical device that received FDA 510(k) clearance on 1997-02-06. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K965038.

When did GORE-TEX SOFT TISSUE PATCH PLUS/DUALMESH PLUS BIOMATERIAL/MYCROMESH PLUS BIOMATERIAL/DUALMESH PLUS BIOMATERIAL WITH HOLE receive FDA 510(k) clearance?

GORE-TEX SOFT TISSUE PATCH PLUS/DUALMESH PLUS BIOMATERIAL/MYCROMESH PLUS BIOMATERIAL/DUALMESH PLUS BIOMATERIAL WITH HOLE received FDA 510(k) clearance on 1997-02-06, under 510(k) number K965038.

Who is the listed applicant for GORE-TEX SOFT TISSUE PATCH PLUS/DUALMESH PLUS BIOMATERIAL/MYCROMESH PLUS BIOMATERIAL/DUALMESH PLUS BIOMATERIAL WITH HOLE?

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-TEX SOFT TISSUE PATCH PLUS/DUALMESH PLUS BIOMATERIAL/MYCROMESH PLUS BIOMATERIAL/DUALMESH PLUS BIOMATERIAL WITH HOLE?

The FDA product code for GORE-TEX SOFT TISSUE PATCH PLUS/DUALMESH PLUS BIOMATERIAL/MYCROMESH PLUS BIOMATERIAL/DUALMESH PLUS BIOMATERIAL WITH HOLE is FTL.

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

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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.