SILCRYST SILVER ANTIMICROBIAL WOUND CREAM, MODEL A-00901 (K063805) - FDA 510(k) Clearance

K063805 is an FDA 510(k) clearance for the SILCRYST SILVER ANTIMICROBIAL WOUND CREAM, MODEL A-00901. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Nucryst Pharmaceuticals, Inc. (Wakefield, US). The FDA issued a Cleared decision on July 13, 2007 after a review of 203 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 Nucryst Pharmaceuticals, Inc. devices