K022127 - AVAGEN WOUND DRESSING (FDA 510(k) Clearance)

K022127 is an FDA 510(k) clearance for the AVAGEN WOUND DRESSING. 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 September 10, 2002 after a review of 71 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.