K202982 - Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) (FDA 510(k) Clearance)

K202982 is an FDA 510(k) clearance for the Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dre.... Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Winner Medical Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 19, 2021 after a review of 384 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.

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