MICROCYN WOUND CARE DRESSING (K041161) - FDA 510(k) Clearance

K041161 is an FDA 510(k) clearance for the MICROCYN WOUND CARE DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Oculus Innovative Sciences, Inc. (Petaluma, US). The FDA issued a Cleared decision on May 3, 2005 after a review of 365 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Oculus Innovative Sciences, Inc. devices