K172570 - ALGS6 Ag Alginate Wound Dressing (FDA 510(k) Clearance)

K172570 is an FDA 510(k) clearance for the ALGS6 Ag Alginate Wound Dressing. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Foshan United Medical Technologies, Ltd. (Foshan, CN). The FDA issued a Cleared decision on May 11, 2018 after a review of 256 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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