K240919 is an FDA 510(k) clearance for the Silk Voice (SMI-04). This device is classified as a System, Vocal Cord Medialization (Class II - Special Controls, product code MIX).
Submitted by Sofregen Medical (Framingham, US). The FDA issued a Cleared decision on May 3, 2024, 30 days after receiving the submission on April 3, 2024.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3620.
| 510(k) Number | K240919 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 2024 |
| Decision Date | May 03, 2024 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | MIX — System, Vocal Cord Medialization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3620 |