K180643 - MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs) (FDA 510(k) Clearance)

K180643 is an FDA 510(k) clearance for the MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs). Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Medcu Technologies , Ltd. (Herzlia, IL). The FDA issued a Cleared decision on November 23, 2018 after a review of 256 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.