# Sofregen Medical

SilkVoice silk fibroin vocal-cord medialization device, the only FDA-cleared silk fibroin ENT device on the US market — Class II under product code MIX (System, Vocal Cord Medialization) and 21 CFR 874.3620; K180631 cleared November 8, 2018 via the Traditional 510(k) pathway (244-day review);…


Source: https://en.bioecon.ru/companies/sofregen-medical/
Updated: 2026-08-15

- Country: United States

## Technologies

- [Silk fibroin (recombinant, biomaterials)](https://en.bioecon.ru/technology/silk-fibroin-recombinant-biomaterials/)