K153565 - DONASORB SILVER WOUND DRESSING (FDA 510(k) Clearance)

K153565 is an FDA 510(k) clearance for the DONASORB SILVER WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Virchow Biotech Pvt, Ltd. (Portland, US). The FDA issued a Cleared decision on September 22, 2016 after a review of 283 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.

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