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FDA 510(k)

VOCALIS GEL

K-Number: K081815 · 2009-01-05

ApplicantCytophil, Inc.
Decision Date2009-01-05
Product CodeMIX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

VOCALIS GEL is the device name listed in this FDA 510(k) record. The listed applicant is Cytophil, Inc.. It received FDA 510(k) clearance on 2009-01-05 under 510(k) number K081815. 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 VOCALIS GEL?

VOCALIS GEL is a medical device that received FDA 510(k) clearance on 2009-01-05. The listed applicant is Cytophil, Inc.. The 510(k) number is K081815.

When did VOCALIS GEL receive FDA 510(k) clearance?

VOCALIS GEL received FDA 510(k) clearance on 2009-01-05, under 510(k) number K081815.

Who is the listed applicant for VOCALIS GEL?

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

What is the FDA product code for VOCALIS GEL?

The FDA product code for VOCALIS GEL 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 Cytophil, 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.

K121795CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANTK102937OSTEOPHIL BETA-TCPK093871PERIOPHIL B-TCPK092788PERIOPHIL BIPHASICK081816VOCALIS AND VOCALIS SMK072219CYTOPHIL TISSUE MARKER

View all 7 devices →

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.K080956MODIFICATION TO VF GEL PLUSCoapt Systems, 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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