Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is W. L. Gore and Associates, Inc.. It received FDA 510(k) clearance on 2022-12-19 under 510(k) 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. The listed applicant is W. L. Gore and Associates, Inc.. The 510(k) number is K222919.

When did GORE® ENFORM Biomaterial receive FDA 510(k) clearance?

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

Who is the listed applicant for GORE® ENFORM Biomaterial?

The FDA 510(k) record lists W. L. Gore and Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GORE® ENFORM Biomaterial?

The FDA product code for GORE® ENFORM Biomaterial is OXF.

Related Clinical Trials

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.

NCT04718168GORE® ENFORM Biomaterial Product StudyRECRUITING

Other records listing W. L. Gore and 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.

PMA P200030SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENTK180919GORE Tri-Lumen CatheterK172567GORE Molding and Occlusion Balloon Catheter

Related Devices (Code: OXF)

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.

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

↑