Clearance Summary
MFUSE (MS001) received FDA 510(k) clearance under submission number K250319, sponsored by Machina Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2025-12-15.
- Submission: K250319
- Applicant / Sponsor: Machina Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Unknown
- Device class:
- Decision date: 2025-12-15
Classification & Regulation
This clearance is catalogued under FDA product code QSY , within the Unknown review panel as a device.