K220566 - Vascette HP (hemostatic pad) (FDA 510(k) Clearance)

K220566 is an FDA 510(k) clearance for the Vascette HP (hemostatic pad). Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Koag, LLC (Vonore, US). The FDA issued a Cleared decision on July 29, 2022 after a review of 151 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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