FDA 510(k)

VF GEL PLUS

K-Number: K071663 · 2008-02-15

Decision Date2008-02-15

Product CodeMIX

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

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 2008-02-15 under 510(k) number K071663. 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 VF GEL PLUS?

VF GEL PLUS is a medical device that received FDA 510(k) clearance on 2008-02-15. The listed applicant is Coapt Systems, Inc.. The 510(k) number is K071663.

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

VF GEL PLUS received FDA 510(k) clearance on 2008-02-15, under 510(k) number K071663.

Who is the listed applicant for 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 VF GEL PLUS?

The FDA product code for VF GEL PLUS is MIX.

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 LIQUIGEL K080956MODIFICATION TO VF GEL PLUS K060248ULTRATINE TRANSBLEPH K060249ULTRATINE FOREHEAD K060828MODIFICATION TO ENDOTINE RIBBON K051415ENDOTINE RIBBON

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Related Devices (Code: MIX)

K240919Silk Voice (SMI-04)Sofregen Medical K180631Silk 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.