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FDA 510(k)

PRECLUDE DURA SUBSTITUTE

K-Number: K953969 · 1995-11-01

ApplicantW. L. Gore & Associates, Inc.
Decision Date1995-11-01
Product CodeGXQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PRECLUDE DURA SUBSTITUTE 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 1995-11-01 under 510(k) number K953969. The device is classified under product code GXQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRECLUDE DURA SUBSTITUTE?

PRECLUDE DURA SUBSTITUTE is a medical device that received FDA 510(k) clearance on 1995-11-01. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K953969.

When did PRECLUDE DURA SUBSTITUTE receive FDA 510(k) clearance?

PRECLUDE DURA SUBSTITUTE received FDA 510(k) clearance on 1995-11-01, under 510(k) number K953969.

Who is the listed applicant for PRECLUDE DURA SUBSTITUTE?

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 PRECLUDE DURA SUBSTITUTE?

The FDA product code for PRECLUDE DURA SUBSTITUTE is GXQ.

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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: GXQ)

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.

K251191Collagen Dura Regeneration Membrane - RepairCollagen Matrix, Inc.K250420Helios Dura Regeneration MatrixHelios Biomedical, Inc.K223445ArtiFasciaNurami Medical , Ltd.K212943SyntheCel Dura RepairSynthes (USA) Products, LLCK183513XenoSure Dura Biologic PatchLeMaitre Vascular, Inc.K172603Cerafix Dura SubstituteAcera Surgical, 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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