LUOFUCON Collagen Wound Dressing (K213598) - FDA 510(k) Clearance

K213598 is an FDA 510(k) clearance for the LUOFUCON Collagen Wound Dressing. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Huizhou Foryou Medical Devices Co., Ltd. (Huizhou, CN). The FDA issued a Cleared decision on September 20, 2022 after a review of 309 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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