MIX · Class II · 21 CFR 874.3620

FDA Product Code MIX: System, Vocal Cord Medialization

Leading manufacturers include Coapt Systems, Inc., Smith & Nephew, Inc. and Cytophil, Inc..

17
Total
17
Cleared
111d
Avg days
1997
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared System, Vocal Cord Medialization Devices (Product Code MIX)

17 devices
1–17 of 17
Cleared May 03, 2024
Silk Voice (SMI-04)
K240919
Sofregen Medical
Ear, Nose, Throat · 30d
Cleared Nov 08, 2018
Silk Voice
K180631
Sofregen Medical, Inc.
Ear, Nose, Throat · 244d
Cleared Apr 06, 2015
Renu Gel
K150400
Cytophil, Inc.
Ear, Nose, Throat · 47d
Cleared Feb 22, 2013
CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT
K121795
Cytophil, Inc.
Ear, Nose, Throat · 248d
Cleared Sep 11, 2009
VF LIQUIGEL
K083783
Coapt Systems, Inc.
Ear, Nose, Throat · 266d
Cleared Apr 25, 2008
MODIFICATION TO VF GEL PLUS
K080956
Coapt Systems, Inc.
Ear, Nose, Throat · 22d
Cleared Feb 15, 2008
VF GEL PLUS
K071663
Coapt Systems, Inc.
Ear, Nose, Throat · 242d
Cleared Apr 18, 2006
JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT
K060815
Bioform Medical, Inc.
Ear, Nose, Throat · 22d
Cleared Jun 26, 2001
LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT
K011554
Biomet, Inc.
Ear, Nose, Throat · 39d
Cleared Jul 26, 2000
VOCOM SILICONE SYSTEM
K001466
Smith & Nephew, Inc.
Ear, Nose, Throat · 77d
Cleared Mar 01, 2000
VOCOM IMPLANT- 8MM
K000533
Smith & Nephew, Inc.
Ear, Nose, Throat · 13d
Cleared Dec 10, 1998
GORE REVOX THYROPLASTY IMPLANT
K983525
W.L. Gore & Associates, Inc.
Ear, Nose, Throat · 63d
Cleared Sep 18, 1997
MONTGOMERY THYROPLASTY IMPLANT SYSTEM
K972317
Boston Medical Products, Inc.
Ear, Nose, Throat · 90d

About Product Code MIX - Regulatory Context

510(k) Submission Activity

17 total 510(k) submissions under product code MIX since 1997, with 17 receiving FDA clearance (average review time: 111 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.