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FDA 510(k)

GORE-TEX MYCROMESH PLUS BIOMATERIAL

K-Number: K946107 · 1995-04-24

ApplicantW. L. Gore & Associates, Inc.
Decision Date1995-04-24
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GORE-TEX MYCROMESH PLUS BIOMATERIAL 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 1995-04-24 under 510(k) number K946107. 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 MYCROMESH PLUS BIOMATERIAL?

GORE-TEX MYCROMESH PLUS BIOMATERIAL is a medical device that received FDA 510(k) clearance on 1995-04-24. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K946107.

When did GORE-TEX MYCROMESH PLUS BIOMATERIAL receive FDA 510(k) clearance?

GORE-TEX MYCROMESH PLUS BIOMATERIAL received FDA 510(k) clearance on 1995-04-24, under 510(k) number K946107.

Who is the listed applicant for GORE-TEX MYCROMESH PLUS BIOMATERIAL?

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 MYCROMESH PLUS BIOMATERIAL?

The FDA product code for GORE-TEX MYCROMESH PLUS BIOMATERIAL is FTL.

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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.

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)

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.

K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim ProductionK253125Parietene™ Flat Sheet MeshMedtronic - Sofradim ProductionK251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc.K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc.K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim ProductionK250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedDavol, Inc.

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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