K140757 - D2 HEMOSTANTIC DRESSING (FDA 510(k) Clearance)

K140757 is an FDA 510(k) clearance for the D2 HEMOSTANTIC DRESSING. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Z-Medica, LLC (Wallingford, US). The FDA issued a Cleared decision on July 17, 2014 after a review of 113 days - within the typical 510(k) review window.

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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