ENLUXTRA HUMIFIBER WOUND DRESSING (K122297) - FDA 510(k) Clearance

K122297 is an FDA 510(k) clearance for the ENLUXTRA HUMIFIBER WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Basf Venture Capital America, Inc. (Florham Park, US). The FDA issued a Cleared decision on August 28, 2012 after a review of 28 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.

View all Basf Venture Capital America, Inc. devices