MFUSE (MS001)— 510(k) K250319

Substantially Equivalent

Machina Medical, Inc.

FDA 510(k) clearance K250319 for MFUSE (MS001), Substantially Equivalent on 2025-12-15. Applicant: Machina Medical, Inc..

Clearance details

Applicant: Machina Medical, Inc.
Product code: Code QSY
Advisory panel: Unknown
Date received: 2025-02-04
Decision date: 2025-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roswell, GA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QSY

product code QSY

Death: 5
Other: 1
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.