K180631 is an FDA 510(k) clearance for the Silk Voice. This device is classified as a System, Vocal Cord Medialization (Class II - Special Controls, product code MIX).
Submitted by Sofregen Medical, Inc. (Medford, US). The FDA issued a Cleared decision on November 8, 2018, 244 days after receiving the submission on March 9, 2018.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3620.
| 510(k) Number | K180631 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 09, 2018 |
| Decision Date | November 08, 2018 |
| Days to Decision | 244 days |
| Submission Type | Traditional |
| 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 |