XENOMEM WOUND MATRIX (K140820) - FDA 510(k) Clearance

K140820 is an FDA 510(k) clearance for the XENOMEM WOUND MATRIX. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Viscus Biologics, LLC (Stillwater, US). The FDA issued a Cleared decision on June 26, 2015 after a review of 451 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

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