MEDLINE COLLAGEN WOUND DRESSING (K060456) - FDA 510(k) Clearance

K060456 is an FDA 510(k) clearance for the MEDLINE COLLAGEN WOUND DRESSING. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on June 19, 2006 after a review of 117 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

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