FDA 510(k)

GORE BIO-A Tissue Reinforcement

K-Number: K163217 · 2017-02-10

Decision Date2017-02-10

Product CodeOXF

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

GORE BIO-A Tissue Reinforcement 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 2017-02-10 under 510(k) number K163217. 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 BIO-A Tissue Reinforcement?

GORE BIO-A Tissue Reinforcement is a medical device that received FDA 510(k) clearance on 2017-02-10. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K163217.

When did GORE BIO-A Tissue Reinforcement receive FDA 510(k) clearance?

GORE BIO-A Tissue Reinforcement received FDA 510(k) clearance on 2017-02-10, under 510(k) number K163217.

Who is the listed applicant for GORE BIO-A Tissue Reinforcement?

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 BIO-A Tissue Reinforcement?

The FDA product code for GORE BIO-A Tissue Reinforcement 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.

NCT02380716ARISE: Evaluation of the GORE® Ascending Stent Graft in the Treatment of DeBakey Type I/II Aortic DissectionCOMPLETED NCT03728985Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic AneurysmsACTIVE_NOT_RECRUITING NCT03821129GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval StudyRECRUITING NCT04100135GORE® CARDIOFORM Septal Occluder Migraine Clinical StudyTERMINATED NCT04718168GORE® ENFORM Biomaterial Product StudyRECRUITING NCT04907240Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Global RegistryACTIVE_NOT_RECRUITING

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

PMA P050006Transcatheter septal occluder PMA P210032SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT PMA P020004SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT PMA P230023Endovascular system for treatment of thoracoabdominal and pararenal aortic lesions PMA P160021Iliac covered stent, arterial PMA P130006System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment

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Related Devices (Code: OXF)

K251224Restrata Soft Tissue Reinforcement (STR)Acera Surgical, Inc.K2433023DMatrix DynaFlex (DynaFlex)Printbio, Inc.K2326023DMatrix Surgical MeshPrintbio, Inc.K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.K172545SERI ContourSofregen Medical, 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.