K081635 - INTEGRA MESHED BILAYER WOUND MATRIX (FDA 510(k) Clearance)

K081635 is an FDA 510(k) clearance for the INTEGRA MESHED BILAYER WOUND MATRIX. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Integra Lifesciences Corp. (Planisboro, US). The FDA issued a Cleared decision on December 4, 2008 after a review of 176 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.