K112191 - HEALEX BIOSPONGE WOUND DRESSING (FDA 510(k) Clearance)

K112191 is an FDA 510(k) clearance for the HEALEX BIOSPONGE WOUND DRESSING. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Bionova Medical, Inc. (Alexandria, US). The FDA issued a Cleared decision on June 5, 2012 after a review of 312 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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