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FDA 510(k)

GORE-TEX REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURATIONS

K-Number: K960292 · 1996-04-15

ApplicantW. L. Gore & Associates, Inc.
Decision Date1996-04-15
Product CodeNPK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GORE-TEX REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURATIONS 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 1996-04-15 under 510(k) number K960292. The device is classified under product code NPK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GORE-TEX REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURATIONS?

GORE-TEX REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURATIONS is a medical device that received FDA 510(k) clearance on 1996-04-15. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K960292.

When did GORE-TEX REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURATIONS receive FDA 510(k) clearance?

GORE-TEX REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURATIONS received FDA 510(k) clearance on 1996-04-15, under 510(k) number K960292.

Who is the listed applicant for GORE-TEX REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURATIONS?

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 REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURATIONS?

The FDA product code for GORE-TEX REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURATIONS is NPK.

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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: NPK)

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.

K221851Lumina-PTFE TitaniumCriteria Industria E Comercio DE Produtos MedicinaisK222549OpenTexPurgo Biologics, Inc.K211554InnoGenic Non-resorbable MembraneCowellmedi Co., Ltd.K210797Bio-MEM Ti Reinforced MembraneB&Medi Co., Ltd.K201187Cytoplast Titanium-Reinforced PTFE MembranesOsteogenics Biomedical, Inc.K171774RPM Reinforced PTFE MeshOsteogenics Biomedical, 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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