K233111 - ALGS2 Ag Alginate Wound Dressing Rx (FDA 510(k) Clearance)

K233111 is an FDA 510(k) clearance for the ALGS2 Ag Alginate Wound Dressing Rx. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Foshan United Medical Technologies, Ltd. (Guangdong Province, CN). The FDA issued a Cleared decision on May 24, 2024 after a review of 240 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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