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FDA 510(k)

GORE REVOX THYROPLASTY IMPLANT

K-Number: K983525 · 1998-12-10

ApplicantW. L. Gore & Associates, Inc.
Decision Date1998-12-10
Product CodeMIX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

GORE REVOX THYROPLASTY 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 1998-12-10 under 510(k) number K983525. The device is classified under product code MIX. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GORE REVOX THYROPLASTY IMPLANT?

GORE REVOX THYROPLASTY IMPLANT is a medical device that received FDA 510(k) clearance on 1998-12-10. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K983525.

When did GORE REVOX THYROPLASTY IMPLANT receive FDA 510(k) clearance?

GORE REVOX THYROPLASTY IMPLANT received FDA 510(k) clearance on 1998-12-10, under 510(k) number K983525.

Who is the listed applicant for GORE REVOX THYROPLASTY 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 GORE REVOX THYROPLASTY IMPLANT?

The FDA product code for GORE REVOX THYROPLASTY IMPLANT is MIX.

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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: MIX)

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.

K240919Silk Voice (SMI-04)Sofregen MedicalK180631Silk VoiceSofregen Medical, Inc.K121795CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANTCytophil, Inc.K083783VF LIQUIGELCoapt Systems, Inc.K081816VOCALIS AND VOCALIS SMCytophil, Inc.K081815VOCALIS GELCytophil, 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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