Identifiers
- 510(k) Number
- K081815 FDA 510(k)
- FDA Product Code
- MIX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.3620 FDA 510(k)
- Regulation Number
- 874.3620 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Vocalis Gel is a biocompatible injectable gel used for vocal cord medialization. It is designed to be injected into soft tissues to address vocal cord conditions.
The device is supplied as a sterile product and is intended for single-use. Vocalis Gel is a Class II device cleared by the FDA under product code MIX and regulation number 874.3620, with the 510(k) number K081815.
Frequently asked questions
What is Vocalis Gel used for?
Vocalis Gel is a biocompatible injectable gel designed for vocal cord medialization. It is injected into soft tissues to address various vocal cord conditions, helping to improve vocal function.
How is Vocalis Gel supplied and is it reusable?
Vocalis Gel is supplied as a sterile product and is intended for single-use only. It should not be reused or resterilized due to potential contamination risks and device integrity concerns.
What is the regulatory status of Vocalis Gel?
Vocalis Gel is a Class II device cleared by the FDA under product code MIX and regulation number 874.3620, with 510(k) number K081815. It was determined to be substantially equivalent through the traditional clearance process.
Who is the manufacturer of Vocalis Gel?
Vocalis Gel is manufactured by Cytophil, Inc., located in Whitefish Bay, Wisconsin. The company specializes in medical devices for vocal cord conditions and related ENT applications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF SECTION 4 510(k) Summary of Safety and Effectiveness, VOCALIS GEL 510 (k) K081815 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K081815 | Class II | Active |
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Manufacturer
- Manufacturer
- Cytophil, Inc.
Sources (1)
- FDA 510(k) K081815 24 fields · synced Sep 25, 2026