FDA 510(k)

GORE® ENFORM Biomaterial

K-Number: K222919 · 2022-12-19

ApplicantW. L. Gore and Associates, Inc.

Decision Date2022-12-19

Product CodeOXF

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

GORE® ENFORM Biomaterial is a medical device manufactured by W. L. Gore and Associates, Inc.. It received FDA 510(k) clearance on 2022-12-19 under approval number K222919. 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 2022-12-19. It is manufactured by W. L. Gore and Associates, Inc.. The 510(k) number is K222919.

When was GORE® ENFORM Biomaterial approved by the FDA?

GORE® ENFORM Biomaterial received FDA 510(k) clearance on 2022-12-19, under approval number K222919.

What company makes GORE® ENFORM Biomaterial?

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

K180919GORE Tri-Lumen Catheter K172567GORE Molding and Occlusion Balloon Catheter PMA P200030SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Related Devices (Code: OXF)

K172545SERI ContourSofregen Medical, Inc. K163217GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc. K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc. K2326023DMatrix Surgical MeshPrintbio, Inc. K251224Restrata Soft Tissue Reinforcement (STR)Acera Surgical, Inc. K2433023DMatrix DynaFlex (DynaFlex)Printbio, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.