K250319 - MFUSE (MS001) (FDA 510(k) Clearance)

K250319 is an FDA 510(k) clearance for the MFUSE (MS001). Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Machina Medical, Inc. (Roswell, US). The FDA issued a Cleared decision on December 15, 2025 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Machina Medical, Inc. devices