LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM (K120181) - FDA 510(k) Clearance

K120181 is an FDA 510(k) clearance for the LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 10.... Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Huizhou Foryou Medical Devices Co., Ltd. (Pennington, US). The FDA issued a Cleared decision on February 14, 2013 after a review of 391 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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