K222909 - Axiostat Gauze (FDA 510(k) Clearance)

K222909 is an FDA 510(k) clearance for the Axiostat Gauze. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Advamedica, Inc. (Cambridge, US). The FDA issued a Cleared decision on April 7, 2023 after a review of 193 days - an extended review cycle.

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. Standard predicate reliance. 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.

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