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FDA 510(k)

GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE

K-Number: K013346 · 2001-12-19

ApplicantW. L. Gore & Associates, Inc.
Decision Date2001-12-19
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE 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 2001-12-19 under 510(k) number K013346. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE?

GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE is a medical device that received FDA 510(k) clearance on 2001-12-19. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K013346.

When did GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE receive FDA 510(k) clearance?

GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE received FDA 510(k) clearance on 2001-12-19, under 510(k) number K013346.

Who is the listed applicant for GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE?

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 DRAPEABLE ST/LT REGENERATIVE MEMBRANE?

The FDA product code for GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE is LYC.

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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: LYC)

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.

K253317Cytrans™ ElashieldGC America, Inc.K253883Bonalive MaxillofacialBonalive , Ltd.K251818BONTREE PLUSHudens Bio Co., Ltd.K244006FG Bone Graft MFull Golden Biotech Co., Ltd.K243745FG Bone Graft BFull Golden Biotech CorporationK241186Synthetic Bone Graft ParticulateShenzhen Dazhou Medical Technology Co., Ltd.

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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