Clearance Summary
Myocene received FDA 510(k) clearance under submission number DEN230051, sponsored by Myocene. The device was reviewed via the Direct premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2025-01-17.
- Submission: DEN230051
- Applicant / Sponsor: Myocene
- Clearance pathway: Direct
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1871
- Decision date: 2025-01-17
Classification & Regulation
This clearance is catalogued under FDA product code SDX and 21 CFR 882.1871, within the Neurology review panel as a Class II device.