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FDA 510(k)

GORE ENFORM Biomaterial

K-Number: K173333 · 2018-04-05

ApplicantW. L. Gore & Associates, Inc.
Decision Date2018-04-05
Product CodeOXF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GORE ENFORM Biomaterial is a medical device manufactured by W. L. Gore & Associates, Inc.. It received FDA 510(k) clearance on 2018-04-05 under approval number K173333. The device is classified under product code OXF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GORE ENFORM Biomaterial?

GORE ENFORM Biomaterial is a medical device that received FDA 510(k) clearance on 2018-04-05. It is manufactured by W. L. Gore & Associates, Inc.. The 510(k) number is K173333.

When was GORE ENFORM Biomaterial approved by the FDA?

GORE ENFORM Biomaterial received FDA 510(k) clearance on 2018-04-05, under approval number K173333.

What company makes GORE ENFORM Biomaterial?

GORE ENFORM Biomaterial is manufactured by W. L. Gore & Associates, Inc..

What is the FDA product code for GORE ENFORM Biomaterial?

The FDA product code for GORE ENFORM Biomaterial is OXF.

Other Devices by W. L. Gore & Associates, Inc.

K160254GORE DrySeal Flex Introducer Sheath K163576GORE SYNECOR Preperitoneal Biomaterial K170740GORE VIABIL Short Wire Biliary Endoprosthesis K163217GORE BIO-A Tissue Reinforcement K181940GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement K191773GORE BIO-A Tissue Reinforcement

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Related Devices (Code: OXF)

K172545SERI ContourSofregen Medical, Inc. K163217GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc. K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc. K2326023DMatrix Surgical MeshPrintbio, Inc. K251224Restrata Soft Tissue Reinforcement (STR)Acera Surgical, Inc. K2433023DMatrix DynaFlex (DynaFlex)Printbio, 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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