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FDA 510(k)

GORETEX SAM FACIAL IMPLANT

K-Number: K942280 · 1994-07-28

ApplicantW. L. Gore & Associates, Inc.
Decision Date1994-07-28
Product CodeFWP
Advisory CommitteeSU
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

GORETEX SAM FACIAL IMPLANT 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 1994-07-28 under 510(k) number K942280. The device is classified under product code FWP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the GORETEX SAM FACIAL IMPLANT?

GORETEX SAM FACIAL IMPLANT is a medical device that received FDA 510(k) clearance on 1994-07-28. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K942280.

When did GORETEX SAM FACIAL IMPLANT receive FDA 510(k) clearance?

GORETEX SAM FACIAL IMPLANT received FDA 510(k) clearance on 1994-07-28, under 510(k) number K942280.

Who is the listed applicant for GORETEX SAM FACIAL IMPLANT?

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 GORETEX SAM FACIAL IMPLANT?

The FDA product code for GORETEX SAM FACIAL IMPLANT is FWP.

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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: FWP)

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.

K254233MEDPOR Customized Implant KitStryker Leibinger GmbH & Co KGK232593FITme Customized Silicone ImplantKeosan Trading Co.K200610Customized Contour ImplantImplantech Associates, Inc.K191130Customized Contour ImplantImplantech Associates, Inc.K191916Stryker CMF MEDPOR Priority Customized Implant KitStryker Leibinger GmbH & Co KGK153508Stryker CMF MEDPOR Customized ImplantStryker

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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