K242100 - SurgiAid Collagen Wound Dressing (HA) (FDA 510(k) Clearance)

K242100 is an FDA 510(k) clearance for the SurgiAid Collagen Wound Dressing (HA). Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Maxigen Biotech, Inc. (Taoyuan, TW). The FDA issued a Cleared decision on October 16, 2025 after a review of 455 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

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