K213652 - Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG) (FDA 510(k) Clearance)

K213652 is an FDA 510(k) clearance for the Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG). Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Cresilon, Inc. (Brooklyn, US). The FDA issued a Cleared decision on June 28, 2023 after a review of 586 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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