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FDA 510(k)

VOCALIS AND VOCALIS SM

K-Number: K081816 · 2009-01-05

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

Device Summary

VOCALIS AND VOCALIS SM 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 K081816. 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 AND VOCALIS SM?

VOCALIS AND VOCALIS SM 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 K081816.

When did VOCALIS AND VOCALIS SM receive FDA 510(k) clearance?

VOCALIS AND VOCALIS SM received FDA 510(k) clearance on 2009-01-05, under 510(k) number K081816.

Who is the listed applicant for VOCALIS AND VOCALIS SM?

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 AND VOCALIS SM?

The FDA product code for VOCALIS AND VOCALIS SM is MIX.

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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 BIPHASICK081815VOCALIS GELK072219CYTOPHIL TISSUE MARKER

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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.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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