K210949 - Foundation Dermal Regeneration Scaffold (DRS) Solo (FDA 510(k) Clearance)

K210949 is an FDA 510(k) clearance for the Foundation Dermal Regeneration Scaffold (DRS) Solo. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Bionova Medical, Inc. (Germantown, US). The FDA issued a Cleared decision on August 11, 2022 after a review of 499 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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