IODOFOAM IODOPHOR FOAM DRESSING (K122634) - FDA 510(k) Clearance

K122634 is an FDA 510(k) clearance for the IODOFOAM IODOPHOR FOAM DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Progressive Wound Care Technologies, LLC (Wayne, US). The FDA issued a Cleared decision on March 12, 2013 after a review of 195 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 Progressive Wound Care Technologies, LLC devices