K070211 - TRAUMARREST AND BLEEDARREST HEMOSTATIC PARTICLES AND FOAM (FDA 510(k) Clearance)

K070211 is an FDA 510(k) clearance for the TRAUMARREST AND BLEEDARREST HEMOSTATIC PARTICLES AND FOAM. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Hemostasis, LLC (St. Paul, US). The FDA issued a Cleared decision on April 5, 2007 after a review of 73 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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