MIX
- 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)
- 17
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K240919 | 2024-05-03 | Sofregen Medical | Silk Voice (SMI-04) |
Official FDA classification page: MIX
Classification and pathway per current FDA publications. Data from openFDA (CC0).