Mr. Gan · haixiao@sungolytest.com · +86 158 2169 5110 · +86 132 4819 8029Mr. Luo · jun.luo@sungoglobal.com · +86 177 5560 4650

MIX

System, Vocal Cord Medialization

Product code
MIX
Device name
System, Vocal Cord Medialization
Device class
Class 2
21 CFR
21 CFR 874.3620
Medical specialty
Ear, Nose, Throat
Marketing pathway
510(K)
Flag
Implant
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
17 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-05-03.

NumberDecision dateApplicantDevice nameSummary
K2409192024-05-03Sofregen MedicalSilk Voice (SMI-04)PDF

1 summaries are archived here for direct download.

Official FDA classification page: MIX
Classification and pathway per current FDA publications. Data from openFDA (CC0).