K151168 - Nexodyn AOS Wound Care Solution (FDA 510(k) Clearance)

K151168 is an FDA 510(k) clearance for the Nexodyn AOS Wound Care Solution. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Apr Applied Pharma Research SA (Balerna, CH). The FDA issued a Cleared decision on December 22, 2015 after a review of 235 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.

View all Apr Applied Pharma Research SA devices