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);…
- Country
- United States
FDA 510(k) K180631 (Nov 2018) + K240919 (May 2024, 30-day Special); 33-pt Laryngoscope 2026 (86.2% vocal improvement)
us
Coverage
| CN | EU | US | |
|---|---|---|---|
| specialty-fine-chem | ✓ | ✓ | ✓ |
Regulatorsfdaemanmpa
Technologies
| Name | Cluster | Risk | |
|---|---|---|---|
| Silk fibroin (recombinant, biomaterials) | specialty-fine-chem | Low | → |
Compiled by BIOECON via the bioecon-brief pipeline.
Compliance
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