Product Code: MIX FDA class 2 21 CFR 874.3620

System, Vocal Cord Medialization

Ear, Nose, Throat

The Vocal Cord Medialization System is a set of implantable devices used in laryngeal framework surgery to reposition or augment the vocal cord, improving voice quality and airway protection in patients with vocal cord paralysis or paresis. Classified as a Class 2 implantable device under 21 CFR 874.3620 within the Ear, Nose, and Throat specialty, it requires 510(k) premarket notification. It carries an implant flag, denoting its surgically placed nature.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: MIX
Device Class: FDA class 2
Regulation Number: 874.3620
Medical Specialty: Ear, Nose, Throat
Review Panel: EN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 17 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K240919	Silk Voice (SMI-04)	May 03, 2024	Substantially Equivalent	Sofregen Medical
K180631	Silk Voice	Nov 08, 2018	Substantially Equivalent	Sofregen Medical, Inc.
K150400	Renu Gel	Apr 06, 2015	Substantially Equivalent	Cytophil, Inc.
K121795	CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT	Feb 22, 2013	Substantially Equivalent	Cytophil, Inc.
K083783	VF LIQUIGEL	Sep 11, 2009	Substantially Equivalent	Coapt Systems, Inc.
K081816	VOCALIS AND VOCALIS SM	Jan 05, 2009	Substantially Equivalent	Cytophil, Inc.
K081815	VOCALIS GEL	Jan 05, 2009	Substantially Equivalent	Cytophil, Inc.
K080956	MODIFICATION TO VF GEL PLUS	Apr 25, 2008	Substantially Equivalent	Coapt Systems, Inc.
K071663	VF GEL PLUS	Feb 15, 2008	Substantially Equivalent	Coapt Systems, Inc.
K070090	RADIESSE LARYNGEAL IMPLANT	Mar 01, 2007	Substantially Equivalent	Bioform Medical, Inc.
K060815	JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT	Apr 18, 2006	Substantially Equivalent	Bioform Medical, Inc.
K033398	LARYNGEAL AUGMENTATION IMPLANT	Dec 12, 2003	Substantially Equivalent	Bioform, Inc.
K011554	LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT	Jun 26, 2001	Substantially Equivalent	Biomet, Inc.
K001466	VOCOM SILICONE SYSTEM	Jul 26, 2000	Substantially Equivalent	Smith & Nephew, Inc.
K000533	VOCOM IMPLANT- 8MM	Mar 01, 2000	Substantially Equivalent	Smith & Nephew, Inc.
K983525	GORE REVOX THYROPLASTY IMPLANT	Dec 10, 1998	Substantially Equivalent	W. L. Gore & Associates, Inc.
K972317	MONTGOMERY THYROPLASTY IMPLANT SYSTEM	Sep 18, 1997	Substantially Equivalent	Boston Medical Products, Inc.