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FDA 510(k)

MODIFICATION TO VF GEL PLUS

K-Number: K080956 · 2008-04-25

ApplicantCoapt Systems, Inc.
Decision Date2008-04-25
Product CodeMIX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO VF GEL PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Coapt Systems, Inc.. It received FDA 510(k) clearance on 2008-04-25 under 510(k) number K080956. 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 MODIFICATION TO VF GEL PLUS?

MODIFICATION TO VF GEL PLUS is a medical device that received FDA 510(k) clearance on 2008-04-25. The listed applicant is Coapt Systems, Inc.. The 510(k) number is K080956.

When did MODIFICATION TO VF GEL PLUS receive FDA 510(k) clearance?

MODIFICATION TO VF GEL PLUS received FDA 510(k) clearance on 2008-04-25, under 510(k) number K080956.

Who is the listed applicant for MODIFICATION TO VF GEL PLUS?

The FDA 510(k) record lists Coapt Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO VF GEL PLUS?

The FDA product code for MODIFICATION TO VF GEL PLUS is MIX.

Related Clinical Trials

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.

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Other records listing Coapt Systems, 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.

K083783VF LIQUIGELK071663VF GEL PLUSK060248ULTRATINE TRANSBLEPHK060249ULTRATINE FOREHEADK060828MODIFICATION TO ENDOTINE RIBBONK051415ENDOTINE RIBBON

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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.K081815VOCALIS GELCytophil, Inc.K081816VOCALIS AND VOCALIS SMCytophil, 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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