DERMADAPT WOUND DRESSING (K061494) - FDA 510(k) Clearance

K061494 is an FDA 510(k) clearance for the DERMADAPT WOUND DRESSING. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Pegasus Biologics, Inc. (Irvine, US). The FDA issued a Cleared decision on September 21, 2006 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.

View all Pegasus Biologics, Inc. devices